Flowmeter, Blood, Cardiovascular
FDA product code DPW · Class II (moderate risk) · 21 CFR 870.2100 · Cardiovascular
138510(k) clearances
0PMA approvals
32recalls
Manufacturers
- Koven Technology, Inc. 7
- Deltex Medical Limited 6
- Perimed, Inc. 6
- Transonic Systems, Inc. 5
- Koven and Assoc., Inc. 5
- Tsi, Inc. 4
- Flosonics Medical 4
- Remington Medical, Inc. 4
- Cardio Metrics, Inc. 4
- Vasamedics, LLC 3
- Cardiosonix, Ltd. 3
- Bach-Simpson , Ltd. 2
- Diagnostic Electronics Corp. 2
- Micro Weiss Electronics 2
- Nihon Kohden America, Inc. 2
- Hewlett-Packard Co. 2
- Imex Medical Systems, Inc. 2
- Rossmax International , Ltd. 2
- Vascular Technology Incorporated 2
- Huntleigh Healthcare, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260700 | BlueDop Vascular ExpertDPW · Traditional | BlueDop Medical, Ltd. | 07/08/2026SE |
| K252810 | FloPatch FP120DPW · Special | Flosonics Medical | 04/24/2026SE |
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock…DPW · Traditional | Remington Medical, Inc. | 11/20/2025SE |
| K251114 | FloPatch FP120DPW · Traditional | Flosonics Medical | 06/20/2025SE |
| K243852 | Elfor-LDPW · Traditional | Elfi-Tech , Ltd. | 04/14/2025SE |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…DPW · Special | Remington Medical, Inc. | 08/30/2024SE |
| K223843 | FloPatch FP120DPW · Traditional | Flosonics Medical | 05/03/2023SE |
| K222242 | FloPatch FP120DPW · Traditional | Flosonics Medical | 12/09/2022SE |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special | Synovis Micro Companies Alliance, Inc. | 04/20/2022SE |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerDPW · Traditional | Remington Medical, Inc. | 01/27/2022SE |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerDPW · Traditional | Remington Medical, Inc. | 10/07/2021SE |
| K201114 | Bidop 7DPW · Traditional | Koven Technology, Inc. | 01/05/2021SE |
| K200337 | FloPatch (FP120)DPW · Traditional | Flosonics Medical (R/A 1929803 Ontario Corp.) | 03/24/2020SE |
| K192966 | FlowMetDPW · Special | Laser Associated Sciences, Inc. | 01/10/2020SE |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesDPW · Abbreviated | Huntleigh Healthcare , Ltd. | 09/06/2019SE |
| K191388 | FloPatch (FP110)DPW · Traditional | Flosonics Medical (R/A 1929803 Ontario Corp.) | 06/21/2019SE |
| K182494 | FlowMet-RDPW · Traditional | Laser Associated Sciences, Inc. | 02/27/2019SE |
| K181269 | iCertaintyDPW · Traditional | Rfpi | 12/14/2018SE |
| K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDPW · Traditional | Deltex Medical Limited | 06/28/2018SE |
| K152930 | PeriFlux6000DPW · Traditional | Perimed AB | 05/05/2016SE |
| K150268 | CerOXDPW · Traditional | Or-Nim Medical , Ltd. | 11/06/2015SE |
| K150347 | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+DPW · Traditional | Deltex Medical Limited | 07/24/2015SE |
| K140740 | Transonic Tissue Perfusion MonitorDPW · Traditional | Transonic Systems, Inc. | 07/23/2015SE |
| K132139 | Deltex Medical Cardioq-Edm+DPW · Traditional | Deltex Medical Limited | 10/10/2013SE |
| K131854 | CeroxDPW · Special | Or-Nim Medical , Ltd. | 09/13/2013SE |
| K111730 | Sonott Flowlab(R)DPW · Abbreviated | Em-Tec GmbH | 01/06/2012SE |
| K112657 | Aureflo Monitoring SystemDPW · Traditional | Transonic Systems, Inc. | 12/21/2011SE |
| K111542 | Deltex Medical Cardioq EdmDPW · Traditional | Deltex Medical Limited | 10/20/2011SE |
| K110438 | Sensilase Pad-IqDPW · Abbreviated | Vasamed, Inc. | 05/04/2011SE |
| K110347 | Doppler MonitorDPW · Special | Cook Vascular, Inc. | 03/16/2011SE |
| K102595 | Medistim Veriqc SystemDPW · Traditional | Medi-Stim Asa | 12/27/2010SE |
| K102433 | Moorvms-Pres Pressure Cuff ControllerDPW · Traditional | Moor Instruments, Ltd. | 11/18/2010SE |
| K082870 | Vti Intraoperative Doppler SystemsDPW · Special | Vascular Technology Incorporated | 10/28/2008SE |
| K062977 | Critiview, Model CRV3DPW · Traditional | Critisense , Ltd. | 02/28/2007SE |
| K051145 | CritiviewDPW · Traditional | Critisense , Ltd. | 01/18/2006SE |
| K052209 | VCS Doppler Transceiver, Model 09-0023-01DPW · Traditional | Vascular Control Systems, Inc. | 09/06/2005SE |
| K050601 | Smartdop 45 Vascular DopplerDPW · Traditional | Koven Technology, Inc. | 04/15/2005SE |
| K050088 | Quantix/Or Blood Flow Monitor; Flexible Probe with Optional Vessel StabilizerDPW · Special | Neoprobe Corp. | 02/08/2005SE |
| K041180 | Quantix or Vessel Stabilizer DeviceDPW · Special | Cardiosonix, Ltd. | 06/07/2004SE |
| K040654 | Sensilase Pad 3000DPW · Abbreviated | Optical Sensors, Inc. | 06/04/2004SE |
| K040228 | Medi-Stim Veriq System, Model VQ1001 - VQ4122DPW · Traditional | Medi-Stim A/S | 04/29/2004SE |
| K040909 | Sono TT Ultrasonic FlowcomputerDPW · Traditional | Em-Tec GmbH | 04/20/2004SE |
| K031931 | Echo Sounder EX-101EX 8 MHZDPW · Traditional | Koven Technology, Inc. | 02/13/2004SE |
| K033424 | Angioflow Meter, Angioflow Antegrade Catheter, Angioflow Retrograde Catheter, Models…DPW · Special | Transonic Systems, Inc. | 12/11/2003SE |
| K031153 | Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model HSJ-05065DPW · Traditional | Arrow Intl., Inc. | 11/25/2003SE |
| K030357 | Quantix/Or DeviceDPW · Traditional | Cardiosonix, Ltd. | 08/20/2003SE |
| K031706 | Cardioq, Model 9051-7005DPW · Traditional | Deltex Medical | 08/06/2003SE |
| K030505 | Capiox Cardiotomy ReservoirDPW · Traditional | Terumo Cardiovascular Systems Corp. | 05/14/2003SE |
| K031091 | Vti 20 MHZ Gated DopplerDPW · Traditional | Vascular Technology Incorporated | 04/23/2003SE |
| K023431 | Quantix/Nd DeviceDPW · Special | Cardiosonix, Ltd. | 11/13/2002SE |
| K013376 | Qflow 500 Perfusion Monitoring SystemDPW · Traditional | Hemedex Incorporated | 05/08/2002SE |
| K013803 | Flowguard DeviceDPW · Traditional | Biosonix , Ltd. | 02/13/2002SE |
| K010452 | Bi-Directional Doppler Volume Flowmeter, Model DVM-4300 & 4300TDPW · Traditional | Koven Technology, Inc. | 02/12/2002SE |
| K011899 | PF 5050 Pressure Unit, Model PF 5050DPW · Traditional | Perimed AB | 11/06/2001SE |
| K002186 | Vascular AssistDPW · Traditional | Huntleigh Healthcare, Inc. | 05/02/2001SE |
| K992529 | Tissue SpectroscopeDPW · Traditional | Vital Medical , Ltd. | 11/17/2000SE |
| K984338 | Jostra HL-20 Twin PumpDPW · Traditional | Jostra Bentley | 08/19/1999SE |
| K992388 | Rossmax Automatic Wristwatch Blood Pressure Monitor, Model RM-4200DPW · Special | Rossmax International , Ltd. | 08/03/1999SE |
| K992387 | Rossmax Automatic Wristwatch Blood Pressure Monitor, Model RM-4100DPW · Special | Rossmax International , Ltd. | 08/03/1999SE |
| K973078 | Wrist Blood Pressure Meter Model SE-330DPW · Traditional | Sein Electronics Co., Ltd. | 05/20/1999SE |
| K982986 | Tubing Blood Flow Meter Model Number HD-800DPW · Traditional | Koven Technology, Inc. | 11/24/1998SE |
| K973198 | VGF-7 Vascular Graft FlowmeterDPW · Traditional | Medicard , Ltd. | 10/14/1998SE |
| K974285 | Periflux System 5000 Modular Laser Doppler System Main Unit Model PF 5001, Including PF…DPW · Traditional | Perimed, Inc. | 05/28/1998SE |
| K970211 | Microlife Automatic Blood Pressure MonitorDPW · Traditional | Micro Weiss Electronics | 04/30/1998SE |
| K970139 | Microlife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIODPW · Traditional | Micro Weiss Electronics | 04/30/1998SE |
| K972213 | MS-700DPW · Traditional | Alan S. Lee | 03/13/1998SE |
| K972798 | Dynemo 3000DPW · Traditional | Sometec, Inc. | 02/24/1998SE |
| K954397 | Bidirectional Doppler W/Waveform DisplayDPW · Traditional | Koven Technology, Inc. | 03/29/1996SE |
| K951369 | EdmDPW · Traditional | Deltex Medical | 11/07/1995SE |
| K951486 | Model PV2000 Vascular MicrolaboratoryDPW · Traditional | Vasamedics, LLC | 06/29/1995SE |
| K942613 | Smartdop 30 Bi-Directional Blood Flow DetectorDPW · Traditional | Koven Technology, Inc. | 12/23/1994SE |
| K932068 | Peritemp PF 4005 HeaterDPW · Traditional | Perimed, Inc. | 12/07/1993SE |
| K921377 | P/MeterDPW · Traditional | Zertl Medical, Inc. | 10/12/1993SE |
| K930227 | MS Disposable Rigid Doppler ProbeDPW · Traditional | Meadox Medicals, Div. Boston Scientific Corp. | 09/16/1993SE |
| K925524 | Cardiometrics Smartwire(Tm)/Flomap(R)DPW · Traditional | Cardio Metrics, Inc. | 08/23/1993SE |
| K922034 | LV-20 Volumeter, 20 MHZ Doppler Blood Flow MeterDPW · Traditional | Titronics Medical Instruments, Inc. | 05/18/1993SE |
| K922368 | Periflux PF4001 Laser Doppler FlowmeterDPW · Traditional | Perimed, Inc. | 02/03/1993SE |
| K922669 | Multidop Model HD-2020 Bi-Directional Blood FlowDPW · Traditional | Koven and Assoc., Inc. | 01/29/1993SE |
| K920333 | Smartdop 20 Bi-Directional Blood Flow DetectorDPW · Traditional | Koven and Assoc., Inc. | 01/22/1993SE |
| K915550 | Mini Doppler II Ultrasound Blood Flow DetectorDPW · Traditional | Koven and Assoc., Inc. | 12/10/1992SE |
| K920844 | Pim 1.0 Laser Doppler Perfusion ImagerDPW · Traditional | Lisca Development AB | 07/21/1992SE |
| K912562 | Abcom 2000DPW · Traditional | Applied Biometrics, Inc. | 01/09/1992SE |
| K912446 | Modif. Laserflo Blood Perfusion Monitor Model BPM2DPW · Traditional | Vasamedics, LLC | 12/12/1991SE |
| K913827 | Model 7700A/77010A/77025A/77030A/77035A Ultra ImagDPW · Traditional | Hewlett-Packard Co. | 11/19/1991SE |
| K911763 | Laserflo(R) Blood Perfusion Monitor (Model BPM2)DPW · Traditional | Vasamedics, LLC | 08/13/1991SE |
| K910049 | Interspec Apogee, ModificationDPW · Traditional | Interspec, Inc. | 04/29/1991SE |
| K905411 | Flowire and FlomapDPW · Traditional | Cardio Metrics, Inc. | 03/29/1991SE |
| K903026 | ES-1000SP II Smart DopDPW · Traditional | Koven and Assoc., Inc. | 02/26/1991SE |
| K904317 | Avalon General Purpose Scanner, Preview GPDPW · Traditional | Avalon Technology Corp. | 02/13/1991SE |
| K904792 | Diagnostic Ultrasound Versadopp 1000DPW · Traditional | Diagnostic Ultrasound Corp. | 01/28/1991SE |
| K903625 | Doppler Needle and Flow MonitorDPW · Traditional | Peripheral Systems Group | 11/07/1990SE |
| K901015 | Wright Pocket Dopplers Vascular & ObstetricDPW · Traditional | Wright Medical Corp. | 11/05/1990SE |
| K903633 | Advance Laser Flowmeter, Alf 21DPW · Traditional | Transonic Systems, Inc. | 10/09/1990SE |
| K901335 | Aloka UST-5514DTU-7.5 Linear Doppler TransducerDPW · Traditional | Ge Medical Systems Information Technologies | 08/10/1990SE |
| K902088 | Modified Software to the Sonos 100 UltrasoundDPW · Traditional | Hewlett-Packard Co. | 08/08/1990SE |
| K901733 | Modified Flocath Pulmonary Artery CatheterDPW · Traditional | Cardio Metrics, Inc. | 07/16/1990SE |
| K896613 | Flat Vascular ProbeDPW · Traditional | Imex Medical Systems, Inc. | 02/16/1990SE |
| K896515 | Laserflo Blood Perfusion Monitor, Model BPM2DPW · Traditional | Tsi, Inc. | 02/13/1990SE |
| K894631 | Nka Model MFV-3100 & MFV-3200 Electro. Blood Flow.DPW · Traditional | Nihon Kohden America, Inc. | 01/19/1990SE |
| K892707 | DVM-4200 Blood FlowmeterDPW · Traditional | Koven and Assoc., Inc. | 07/28/1989SE |
| K890828 | Periflux PF3DPW · Traditional | Perimed, Inc. | 06/20/1989SE |
| K882138 | Imexlab 3000 Vascular Diagnostic RecorderDPW · Traditional | Imex Medical Systems, Inc. | 11/07/1988SE |
| K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403ADPW · Traditional | Tsi, Inc. | 09/19/1988SE |
| K882593 | Modified Continuous Cardiac Output Monitor SystemDPW · Traditional | Cardio Metrics, Inc. | 08/29/1988SE |
| K872048 | Transonic FlowmeterDPW · Traditional | Transonic Systems, Inc. | 06/21/1988SE |
| K874885 | Lawrence L3000 Cardiac Output MonitorDPW · Traditional | Lawrence Medical Systems, Inc. | 02/05/1988SE |
| K871490 | Colorview 860 or SSD-860 Pulse Echo/ModificationDPW · Traditional | Ge Medical Systems Information Technologies | 12/07/1987SE |
| K872068 | High Frequency Linear Array (Hfla) ScanheadDPW · Traditional | Advanced Technology Laboratories, Inc. | 09/30/1987SE |
| K864259 | Modified Laserflo Blood Perfusion MonitorDPW · Traditional | Tsi, Inc. | 02/20/1987SE |
| K853952 | Metriflow AFM-100 Peripheral Vascular Blood FlowmeDPW · Traditional | Metriflow, Inc. | 01/05/1987SE |
| K863210 | VELCOM-100DPW · Traditional | Waters Instruments, Inc. | 11/26/1986SE |
| K862720 | VASOFLO-3 & Extravascular Blood Flow ProbesDPW · Traditional | Sonicaid, Inc. | 11/17/1986SE |
| K861023 | Dopplex, Pulsed/Continuous Wave DoppolerDPW · Traditional | Diagnostic Electronics Corp. | 11/17/1986SE |
| K862841 | High Velocity CW Doppler SystemDPW · Traditional | Biosound, Inc. | 11/10/1986SE |
| K860766 | Millar Pulsed Doppler VelocimeterDPW · Traditional | Millar Instruments, Inc. | 07/29/1986SE |
| K860651 | Micron, Microvascular DopplerDPW · Traditional | Diagnostic Electronics Corp. | 07/18/1986SE |
| K854500 | Heater Probe-Access for Medpacific LD5000 Laser -DPW · Traditional | Medpacific Corp. | 02/26/1986SE |
| K850137 | Teca TC2-64 Transcranial DopplerDPW · Traditional | Teca, Inc. | 08/14/1985SE |
| K851057 | Laserflo Blood Perfusion Monitor 403DPW · Traditional | Tsi, Inc. | 06/24/1985SE |
| K840522 | Recomed Blood-Flow Meter H236-052-02DPW · Traditional | Litton Medical Electronics | 05/16/1985SE |
| K840169 | Phonoangiographic Spectral AnalyzerDPW · Traditional | Biotronics Instruments | 03/01/1985SE |
| K844631 | Periflux PF-2DPW · Traditional | Medex, Inc. | 02/20/1985SE |
| K821373 | Xomed Patency MonitorDPW · Traditional | Xomed, Inc. | 07/08/1982SE |
| K820742 | Nihon Kohden Blood Flowmeters #MFV-1100DPW · Traditional | Nihon Kohden America, Inc. | 04/15/1982SE |
| K820272 | Cliniflow II, #701, Electromagn. Bld. SyDPW · Traditional | Carolina Medical Electronics | 03/12/1982SE |
| K812005 | Capillary Perfusion Monitor #LD5000DPW · Traditional | Nuclear Pacific, Inc. | 02/04/1982SE |
| K811616 | Bach-Simpson Model TS266DPW · Traditional | Bach-Simpson , Ltd. | 08/13/1981SE |
| K811615 | Bach-Simpson Model BVM30DPW · Traditional | Bach-Simpson , Ltd. | 08/13/1981SE |
| K811376 | Ultrasonic QFM System 1000DPW · Traditional | Narco Bio-Systems | 08/13/1981SE |
| K811246 | Doppler Ultrasound Blood FlowmeterDPW · Traditional | Irex Corp. | 08/12/1981SE |
| K810561 | Dopscan Model 1050DPW · Traditional | Carolina Medical Electronics | 04/10/1981SE |
| K801802 | Electromagnetic Blood & Arterial GaugeDPW · Traditional | Medical Testing System, Inc. | 01/02/1981SE |
| K800151 | Emit Tobramycin ControlDPW · Traditional | Syva Co. | 02/05/1980SE |
| K791418 | VasculizerDPW · Traditional | Diagnostics Intl. | 10/04/1979SE |
| K780302 | Blood Flowmeter SystemDPW · Traditional | Medtronic Vascular | 04/21/1978SE |
| K770115 | Arterial Diagnostic Unit (Adu)DPW · Traditional | Medical Electronic Devices, Inc. | 02/01/1977SE |
| K761288 | P-1 Ultrasonic ArteriographDPW · Traditional | D. Eugene Hokanson | 12/28/1976SE |
| K760751 | Continuous Wave DopplerDPW · Traditional | Medsonics | 10/13/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1631-2026 Class II | Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal…Product labeling includes a fetal indication for use that is not cleared under its 510(k). | Koven Technology, Inc. | 03/04/2026Open, Classified |
| Z-0410-2026 Class II | Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog…Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the… | Medistim Asa | 09/26/2025Open, Classified |
| Z-2517-2025 Class III | FloPatch FP120, REF: FP120-FOT01-005Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when… | Flosonics Medical (R/A 1929803 ONTARIO CORP.) | 08/07/2025Open, Classified |
| Z-2208-2023 Class II | GEM FLOW COUPLER Monitor, PN 5156-00000-011An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue… | Baxter Healthcare Corporation | 06/19/2023Open, Classified |
| Z-3026-2018 Class II | VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910…Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver | Vascular Technology, Inc. | 06/19/2018Terminated |
| Z-0719-2018 Class II | MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes…A system component overheated causing melting of the connector and emission of smoke through the systems… | Medistim Asa | 04/25/2017Terminated |
| Z-1631-2016 Class II | GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC…Instructions for use booklet may puncture the outer Tyvek lid. | Baxter Healthcare Corp. | 04/21/2016Terminated |
| Z-1630-2016 Class II | GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC…Instructions for use booklet may puncture the outer Tyvek lid. | Baxter Healthcare Corp. | 04/21/2016Terminated |
| Z-1629-2016 Class II | GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC…Instructions for use booklet may puncture the outer Tyvek lid. | Baxter Healthcare Corp. | 04/21/2016Terminated |
| Z-1628-2016 Class II | GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC.…Instructions for use booklet may puncture the outer Tyvek lid. | Baxter Healthcare Corp. | 04/21/2016Terminated |
| Z-1627-2016 Class II | GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC…Instructions for use booklet may puncture the outer Tyvek lid. | Baxter Healthcare Corp. | 04/21/2016Terminated |
| Z-2729-2015 Class II | Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | Transonic Systems Inc | 07/27/2015Terminated |
| Z-2728-2015 Class II | Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | Transonic Systems Inc | 07/27/2015Terminated |
| Z-2727-2015 Class II | Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | Transonic Systems Inc | 07/27/2015Terminated |
| Z-2726-2015 Class II | Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | Transonic Systems Inc | 07/27/2015Terminated |
| Z-2725-2015 Class II | Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | Transonic Systems Inc | 07/27/2015Terminated |
| Z-2724-2015 Class II | Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | Transonic Systems Inc | 07/27/2015Terminated |
| Z-2723-2015 Class II | Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | Transonic Systems Inc | 07/27/2015Terminated |
| Z-2722-2015 Class II | Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | Transonic Systems Inc | 07/27/2015Terminated |
| Z-2721-2015 Class II | Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | Transonic Systems Inc | 07/27/2015Terminated |
| Z-2720-2015 Class II | Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | Transonic Systems Inc | 07/27/2015Terminated |
| Z-2126-2014 Class II | FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in…Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not… | Baxter Healthcare Corporation | 07/11/2014Terminated |
| Z-2001-2014 Class II | VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is…Report of the product penetrating the sterile barrier; this could render the product unsterile. | Vascular Technology, Inc. | 05/28/2014Terminated |
| Z-2000-2014 Class II | 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is…Report of the product penetrating the sterile barrier; this could render the product unsterile. | Vascular Technology, Inc. | 05/28/2014Terminated |
| Z-1999-2014 Class II | 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended…Report of the product penetrating the sterile barrier; this could render the product unsterile. | Vascular Technology, Inc. | 05/28/2014Terminated |
| Z-1998-2014 Class II | 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended…Report of the product penetrating the sterile barrier; this could render the product unsterile. | Vascular Technology, Inc. | 05/28/2014Terminated |
| Z-0443-2013 Class II | Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the…Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS… | Parks Medical Electronics, Inc | 08/08/2012Terminated |
| Z-0132-2011 | PD Access Vascular Access Device. Escalon Vascular Access, Inc., 2440 South 179th…The packaging of the vascular access device may potentially become damaged, compromising the sterility of… | Escalon Medical Corp | 05/05/2010Terminated |
| Z-0673-2008 | Parks Medical Dual Frequency Doppler Vascular Flow Detector, Model 915-BL (finished…Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure… | Parks Medical Electronics Inc | 11/08/2007Terminated |
| Z-0672-2008 | Parks Medical Ultrasonic Doppler Flow Detector, Model 811-BTS (finished assembly without…Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure… | Parks Medical Electronics Inc | 11/08/2007Terminated |
| Z-0671-2008 | Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model 811-BL…Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure… | Parks Medical Electronics Inc | 11/08/2007Terminated |
| Z-0670-2008 | Parks Medical Ultrasonic Doppler Flow Detector, Model 811-B (finished assembly without…Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure… | Parks Medical Electronics Inc | 11/08/2007Terminated |