Medical Device Technologies, Inc.
Medical device manufacturer in Gainesville, FL.
46510(k) clearances
0PMA approvals
49recalls
Device types
- KNW Instrument, Biopsy 15
- FGE Stents, Drains And Dilators For The Biliary… 4
- DRC Trocar 3
- GAA Needle, Aspiration And Injection, Disposable 3
- NEU Marker, Radiographic, Implantable 2
- FDX Endoscopic Cytology Brush 2
- DQX Wire, Guide, Catheter 2
- KNY Accessories, Catheter, G-U 2
- LJE Catheter, Nephrostomy 2
- FMI Needle, Hypodermic, Single Lumen 1
- FOZ Catheter, Intravascular, Therapeutic… 1
- MMX Device, Percutaneous Retrieval 1
- DYB Introducer, Catheter 1
- MDG System, Intrafallopian Cannula 1
- DQO Catheter, Intravascular, Diagnostic 1
- LKF Cannula, Manipulator/Injector, Uterine 1
- FEW Catheter, Malecot 1
- EXF Bag, Bile Collecting 1
- IWJ System, Applicator, Radionuclide, Manual 1
- DWO Needle, Biopsy, Cardiovascular 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K101832 | Biopince Ultra Full Core Biopsy InstrumentKNW · Traditional | 08/27/2010SE |
| K053518 | Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorNEU · Special | 01/26/2006SE |
| K051421 | Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorNEU · Traditional | 08/30/2005SE |
| K050873 | Canalizer Hydrophilic Guide WireDQX · Traditional | 05/26/2005SE |
| K043523 | Interv Brand Snarelok Bone Marrow Biopsy NeedleKNW · Traditional | 02/11/2005SE |
| K042464 | V-Core Full Core Breast Biopsy InstrumentKNW · Traditional | 09/30/2004SE |
| K040427 | Fibrex Catheter Patency DeviceFOZ · Traditional | 05/03/2004SE |
| K031442 | PBN GuidewiresDQX · Traditional | 08/13/2003SE |
| K021606 | En-Snare Endovascular Snare and CatheterMMX · Traditional | 05/31/2002SE |
| K011790 | Microcruiser Plus Introducer SetDYB · Traditional | 09/05/2001SE |
| K000620 | PBN Fallopian Tube Catheter SystemMDG · Traditional | 10/30/2000SE |
| K002416 | Golden-Rule Scaling CatheterDQO · Traditional | 09/11/2000SE |
| K000433 | PBN Hystero-Salpingography Catheter SetLKF · Traditional | 06/16/2000SE |
| K990808 | PBN DilatorsFGE · Traditional | 11/26/1999SE |
| K990839 | Tru-Core I Reusable Biopsy InstrumentKNW · Traditional | 05/20/1999SE |
| K991097 | PBN Drainage Catheter GuidewiresKNY · Traditional | 04/23/1999SE |
| K982960 | Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy InstrumentKNW · Traditional | 09/23/1998SE |
| K982085 | Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy InstrumentKNW · Traditional | 07/17/1998SE |
| K980193 | Manan General Utility Drainage CatheterLJE · Traditional | 05/27/1998SE |
| K980192 | Manan Nephrostomy Drainage CatheterLJE · Traditional | 05/27/1998SE |
| K980372 | Manan VS Access Needle/SetFGE · Traditional | 04/27/1998SE |
| K980227 | Manan Galactography KitFMI · Traditional | 04/23/1998SE |
| K981258 | Manan Malecot Basket Drainage CatheterFEW · Traditional | 04/22/1998SE |
| K981229 | Manan Manta Catheter Fixation DiskKNY · Traditional | 04/22/1998SE |
| K974745 | Manan Gwi Guide Wire IntroducerDRC · Traditional | 04/06/1998SE |
| K974743 | MananDRC · Traditional | 04/06/1998SE |
| K974742 | Manan Potts-Cournand NeedleDRC · Traditional | 04/06/1998SE |
| K980452 | Manan Liver Biopsy KitKNW · Traditional | 02/18/1998SE |
| K980226 | Manan Pro-Mag Automatic Biopsy SystemKNW · Traditional | 02/18/1998SE |
| K980191 | Manan Biliary Drainage CatheterFGE · Traditional | 02/09/1998SE |
| K980196 | MD Tech Biopsy Set for Bone and Bone MarrowKNW · Traditional | 02/03/1998SE |
| K980122 | Manan Soft Tissue Biopsy NeedlesKNW · Traditional | 01/30/1998SE |
| K980005 | Manan D BagEXF · Traditional | 01/30/1998SE |
| K980004 | Manan General Purpose Introducer NeedleKNW · Traditional | 01/09/1998SE |
| K974815 | Manan(Tm) Introducer Sheath/NeedleFGE · Traditional | 01/09/1998SE |
| K974814 | Manan(Tm) Super-Core Biopsy NeedlesKNW · Traditional | 01/09/1998SE |
| K974766 | Manan Techna-Cut Aspiration NeedleKNW · Traditional | 01/08/1998SE |
| K974741 | Manan Accura NeedleGAA · Traditional | 01/08/1998SE |
| K965037 | Cell Recovery SystemFDX · Traditional | 01/08/1997SE |
| K962969 | Medical Device Technologies, Inc.UltraKNW · Traditional | 12/06/1996SE |
| K961959 | MD Tech Biopsy Set for Bone and Bone MarrowGAA · Traditional | 07/19/1996SE |
| K960004 | Cell Recovery SystemFDX · Traditional | 03/20/1996SE |
| K944522 | Morganstern Prostate Stabilization and Seeding KitIWJ · Traditional | 02/24/1995SE |
| K944837 | Medical Device Technologies Manual Biopsy NeedleKNW · Traditional | 10/14/1994SE |
| K921418 | Ultra-Core Biopsy NeedlesDWO · Traditional | 06/19/1992SE |
| K915417 | Kopan's TargetGAA · Traditional | 01/14/1992SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0246-2012 | Angiotech***TLok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0245-2012 | Angiotech*** Custom Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0244-2012 | Angiotech*** Custom Bone Marrow Tray for Louis Weiss Memorial Hospital***1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0243-2012 | Angiotech***General Biopsy Tray*** 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 1 - 5cc…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0242-2012 | Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 4 -Towel; 1 -19ga x…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0241-2012 | Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 1 - #11 Mini Scalpel…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0240-2012 | Angiotech***Custom General Biopsy Tray for St. Johns Mercy Hospital*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0239-2012 | Angiotech***Custom General Biopsy Tray for Palos Community Hospital*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0238-2012 | Angiotech***Custom General Biopsy Tray for OMA North of Oklahoma City*** 1 - 60cc…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0237-2012 | Angiotech***Custom General Biopsy Tray for University of Rochester Medical Center***1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0236-2012 | Angiotech***Custom General Biopsy Tray for Emory University Hospital*** 1 - CSR Wrap 48"…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0235-2012 | Angiotech***Custom Bone Marrow Tray for High Point Regional Hospital*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0234-2012 | Angiotech***Custom Bone Marrow Tray for Hackensack University Medical Center*** 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0233-2012 | Angiotech***Custom Bone Marrow Tray*** 1 - #11 Mini Scalpel; 1 -Fenestrated Drape; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0232-2012 | Angiotech***Custom Bone Marrow Tray for Tyler Hematology Oncology*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0231-2012 | Angiotech***Custom Bone Marrow Tray for Kaiser Foundation Hospitals*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0230-2012 | Angiotech***Custom Bone Marrow Tray*** 1 - #11 Mini Scalpel; 1 - 20ga x 1-1/2" Needle; 1…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0229-2012 | Angiotech***Custom Bone Marrow Tray for University of CA, Davis*** 1 - 10cc Syringe L/L…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0228-2012 | Angiotech***Custom Bone Marrow Tray for University of Chicago*** 2- 20ga x 1 " Safety…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0227-2012 | Angiotech***Custom Bone Marrow Tray for New York Hospital/Cornell Medical Center*** 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0226-2012 | Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0225-2012 | Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0224-2012 | Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0223-2012 | Angiotech***T-Lok Bone Marrow Tray w/ Safety Needles***1 - #11 Retractable Scalpel; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0222-2012 | Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0221-2012 | Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0220-2012 | Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0219-2012 | Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0218-2012 | Angiotech***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2"…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0217-2012 | Angiotech***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2"…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0216-2012 | Angiotech***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2"…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0215-2012 | Angiotech***HSG Procedure Tray 7Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1-…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0214-2012 | Angiotech***HSG Procedure Tray 5Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1-…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0025-2011 | Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable…Medical Device Technologies, Inc., dba Angiotech, Gaineville, Florida is recalling Tru-Core II Disposable… | 07/02/2010Terminated |
| Z-2024-2010 | Angiotech Needle Guide. Needle Guide for Lorad Stereo Loc. STERILE. Product Number:…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2023-2010 | Angiotech Drainage Cather. SKATER Centesis Cather XFr. STERILE. Product Number:…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2022-2010 | Angiotech Prostate Stabilization Set. Prostate Stabilization Set. STERILE. Product…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2021-2010 | Angiotech Access Needle. A) Hawkins Blunt Needle. STERILE. Product Number: 216057…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2020-2010 | Angiotech Galactography Kit. Galactography Kit 30ga with Straight Cannula and…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2019-2010 | Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2018-2010 | Angiotech Vascular Access Needle. A) "Modified Potts/Cournand" Needle. STERILE. Product…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2017-2010 | Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2016-2010 | Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2015-2010 | Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-0453-2009 | Angiotech, Bone Marrow Harvest Needle, Medical Device Technologies, Inc. The device is…Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray. | 07/16/2008Terminated |
| Z-0452-2009 | Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device…Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray. | 07/16/2008Terminated |
| Z-0451-2009 | Angiotech, Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is…Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray. | 07/16/2008Terminated |
| Z-0450-2009 | Angiotech, Bone Marrow Aspiration Needle, Medical Device Technologies, Inc. Individual…Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray. | 07/16/2008Terminated |
| Z-1878-2008 | Hawkins III Breast Localization Needle. Product number 243075. The product is used in…The sterility of the product cannot be guaranteed. | 05/06/2008Terminated |