Electromedics, Inc.
Medical device manufacturer in Moonachie, NJ.
42510(k) clearances
0PMA approvals
0recalls
Device types
- FLL Continuous Measurement Thermometer 10
- CAC Apparatus, Autotransfusion 7
- DTN Reservoir, Blood, Cardiopulmonary Bypass 5
- DTR Heat-Exchanger, Cardiopulmonary Bypass 3
- DRS Transducer, Blood-Pressure, Extravascular 2
- DTM Filter, Blood, Cardiopulmonary Bypass… 2
- JFC System, Pressure Measurement, Intermittent 1
- GEI Electrosurgical, Cutting & Coagulation &… 1
- BYZ Trap, Sterile Specimen 1
- KCY Tourniquet, Pneumatic 1
- DTP Defoamer, Cardiopulmonary Bypass 1
- DWB Pump, Blood, Cardiopulmonary Bypass, Roller… 1
- KOD Catheter, Urological 1
- DTZ Oxygenator, Cardiopulmonary Bypass 1
- BZW Stethoscope, Esophageal 1
- LGZ Warmer, Thermal, Infusion Fluid 1
- KRI Accessory Equipment, Cardiopulmonary Bypass 1
- DWE Tubing, Pump, Cardiopulmonary Bypass 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K073616 | Fas-Clean Electrosurgical Coated Active BladeGEI · Traditional | 07/23/2008SE |
| K934964 | Electromedics Tympanic Temperature SensorFLL · Traditional | 03/07/1994SE |
| K933832 | Electromedics HG (Hydrogel) Series Skin Temperature SensorFLL · Traditional | 01/28/1994SE |
| K934355 | Electromedics Blood Heat ExchangerDTR · Traditional | 12/03/1993SE |
| K930154 | EL2-SERIES Blood Collection ReervoirDTN · Traditional | 07/01/1993SE |
| K926250 | Electromedics El-Series Cardiotomy ReservoirDTN · Traditional | 02/19/1993SE |
| K925412 | Electromedics Tissue Trap/ #TT280BYZ · Traditional | 02/05/1993SE |
| K915737 | Autotransfusion Blood Collection ReservoirDTN · Traditional | 09/03/1992SE |
| K910238 | Portable Auto Transfusion System 500CAC · Traditional | 06/19/1991SE |
| K910935 | Modified Pyrogen TestingDTM · Traditional | 05/16/1991SE |
| K902723 | Arterial Blood Filter Electro. Air* Star 40 and 20DTM · Traditional | 12/13/1990SE |
| K903392 | Electromedics BT422-120 and BT422-40CAC · Traditional | 09/06/1990SE |
| K893218 | AP900/PRP Module and Accessories, ModificationCAC · Traditional | 06/12/1990SE |
| K900104 | TCPM II Tourniquet Cuff Pressure MonitorKCY · Traditional | 03/15/1990SE |
| K873561 | Electromedics D1079EDTR · Traditional | 11/05/1987SE |
| K871847 | BT-795/ATSCAC · Traditional | 06/19/1987SE |
| K860306 | BT-795/P Automated AutotransCAC · Traditional | 03/06/1986SE |
| K842391 | Acr 2500 Cardiotomy Reservoir FilterDTN · Traditional | 05/21/1985SE |
| K844803 | Polyester Cardiotomy Reservoir, Filtered & UnfilteDTP · Traditional | 04/29/1985SE |
| K832897 | Model TTPM Time Temp. Pressure MonitorDRS · Traditional | 03/22/1984SE |
| K832272 | Tourniquet Cuff Pressure Monitor #TcpmLDQ · Traditional | 11/28/1983SE |
| K831458 | Cardioplegia Recirculation Sys-Bl 705/ADWB · Traditional | 10/20/1983SE |
| K831743 | Sterile Foley Catheters & UrologicalKOD · Traditional | 09/12/1983SE |
| K830639 | Hi Flex D-700 Modular Bubble Oxygena-DTZ · Traditional | 05/25/1983SE |
| K830592 | Dispos. Type T Thermocouple Temp.ProbeFLL · Traditional | 05/18/1983SE |
| K830735 | BT 795/A AutotransCAC · Traditional | 05/02/1983SE |
| K823681 | Model Icpm & AccessoriesJFC · Traditional | 02/23/1983SE |
| K823126 | Model SA-1 Stethoscope Audio AmplifierBZW · Traditional | 11/16/1982SE |
| K822098 | BT 794-BLOOD/FLUID WarmerLGZ · Traditional | 08/20/1982SE |
| K822097 | D645-BACTERIOLOGICAL Gas Line FilterKRI · Traditional | 07/30/1982SE |
| K813264 | D6ZO Disposable Heat ExchangerDTR · Traditional | 07/06/1982SE |
| K813459 | Reusable & Disposable Temp. ProbesFLL · Traditional | 03/26/1982SE |
| K812455 | Sucker Cardiotomy Return, C.P. BypassDTN · Traditional | 10/23/1981SE |
| K812292 | Autotrans BT795CAC · Traditional | 10/23/1981SE |
| K812758 | Physiological Pressure TransducerDRS · Traditional | 10/20/1981SE |
| K803277 | Tygon TubingDWE · Traditional | 01/13/1981SE |
| K771996 | Telethermometer Model T T-100FLL · Traditional | 11/22/1977SE |
| K771995 | Electrotherm Models TC-100 & M-99FLL · Traditional | 11/22/1977SE |
| K771999 | Electrotherm Models F&C18,14,78, F84FLL · Traditional | 11/15/1977SE |
| K771998 | Temp-A-Lert Model TA-986FLL · Traditional | 11/15/1977SE |
| K771997 | Telethermometer Model T T-400FLL · Traditional | 11/15/1977SE |
| K771994 | Electrotherm Model HT-1FLL · Traditional | 11/02/1977SE |