Company ยท US
Electromedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2008. Name variants (Inc, Corp, punctuation) are merged.
42510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| 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, Arterial Line | 2 |
| BYZ | Trap, Sterile Specimen | 1 |
| BZW | Stethoscope, Esophageal | 1 |
| DTP | Defoamer, Cardiopulmonary Bypass | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 1 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| JFC | System, Pressure Measurement, Intermittent | 1 |
| KCY | Tourniquet, Pneumatic | 1 |
| KOD | Catheter, Urological | 1 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 1 |
| LDQ | 1 | |
| LGZ | Warmer, Thermal, Infusion Fluid | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 2008 | K073616 | FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE Electromedics Co. , Ltd. | GEI |
| Mar 7, 1994 | K934964 | ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR Electromedics, Inc. | FLL |
| Jan 28, 1994 | K933832 | ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR Electromedics, Inc. | FLL |
| Dec 3, 1993 | K934355 | ELECTROMEDICS BLOOD HEAT EXCHANGER Electromedics, Inc. | DTR |
| Jul 1, 1993 | K930154 | EL2-SERIES BLOOD COLLECTION REERVOIR Electromedics, Inc. | DTN |
| Feb 19, 1993 | K926250 | ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR Electromedics, Inc. | DTN |
| Feb 5, 1993 | K925412 | ELECTROMEDICS TISSUE TRAP/ #TT280 Electromedics, Inc. | BYZ |
| Sep 3, 1992 | K915737 | AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR Electromedics, Inc. | DTN |
| Jun 19, 1991 | K910238 | PORTABLE AUTO TRANSFUSION SYSTEM 500 Electromedics, Inc. | CAC |
| May 16, 1991 | K910935 | MODIFIED PYROGEN TESTING Electromedics, Inc. | DTM |
| Dec 13, 1990 | K902723 | ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 Electromedics, Inc. | DTM |
| Sep 6, 1990 | K903392 | ELECTROMEDICS BT422-120 AND BT422-40 Electromedics, Inc. | CAC |
| Jun 12, 1990 | K893218 | AP900/PRP MODULE AND ACCESSORIES, MODIFICATION Electromedics, Inc. | CAC |
| Mar 15, 1990 | K900104 | TCPM II TOURNIQUET CUFF PRESSURE MONITOR Electromedics, Inc. | KCY |
| Nov 5, 1987 | K873561 | ELECTROMEDICS D1079E Electromedics, Inc. | DTR |
| Jun 19, 1987 | K871847 | BT-795/ATS Electromedics, Inc. | CAC |
| Mar 6, 1986 | K860306 | BT-795/P AUTOMATED AUTOTRANS Electromedics, Inc. | CAC |
| May 21, 1985 | K842391 | ACR 2500 CARDIOTOMY RESERVOIR FILTER Electromedics, Inc. | DTN |
| Apr 29, 1985 | K844803 | POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE Electromedics, Inc. | DTP |
| Mar 22, 1984 | K832897 | MODEL TTPM TIME TEMP. PRESSURE MONITOR Electromedics, Inc. | DRS |
| Nov 28, 1983 | K832272 | TOURNIQUET CUFF PRESSURE MONITOR #TCPM Electromedics, Inc. | LDQ |
| Oct 20, 1983 | K831458 | CARDIOPLEGIA RECIRCULATION SYS-BL 705/A Electromedics, Inc. | DWB |
| Sep 12, 1983 | K831743 | STERILE FOLEY CATHETERS & UROLOGICAL Electromedics, Inc. | KOD |
| May 25, 1983 | K830639 | HI FLEX D-700 MODULAR BUBBLE OXYGENA- Electromedics, Inc. | DTZ |
| May 18, 1983 | K830592 | DISPOS. TYPE T THERMOCOUPLE TEMP.PROBE Electromedics, Inc. | FLL |
| May 2, 1983 | K830735 | BT 795/A AUTOTRANS Electromedics, Inc. | CAC |
| Feb 23, 1983 | K823681 | MODEL ICPM & ACCESSORIES Electromedics, Inc. | JFC |
| Nov 16, 1982 | K823126 | MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER Electromedics, Inc. | BZW |
| Aug 20, 1982 | K822098 | BT 794-BLOOD/FLUID WARMER Electromedics, Inc. | LGZ |
| Jul 30, 1982 | K822097 | D645-BACTERIOLOGICAL GAS LINE FILTER Electromedics, Inc. | KRI |
| Jul 6, 1982 | K813264 | D6ZO DISPOSABLE HEAT EXCHANGER Electromedics, Inc. | DTR |
| Mar 26, 1982 | K813459 | REUSABLE & DISPOSABLE TEMP. PROBES Electromedics, Inc. | FLL |
| Oct 23, 1981 | K812455 | SUCKER CARDIOTOMY RETURN, C.P. BYPASS Electromedics, Inc. | DTN |
| Oct 23, 1981 | K812292 | AUTOTRANS BT795 Electromedics, Inc. | CAC |
| Oct 20, 1981 | K812758 | PHYSIOLOGICAL PRESSURE TRANSDUCER Electromedics, Inc. | DRS |
| Jan 13, 1981 | K803277 | TYGON TUBING Electromedics, Inc. | DWE |
| Nov 22, 1977 | K771996 | TELETHERMOMETER MODEL T T-100 Electromedics, Inc. | FLL |
| Nov 22, 1977 | K771995 | ELECTROTHERM MODELS TC-100 & M-99 Electromedics, Inc. | FLL |
| Nov 15, 1977 | K771999 | ELECTROTHERM MODELS F&C18,14,78, F84 Electromedics, Inc. | FLL |
| Nov 15, 1977 | K771998 | TEMP-A-LERT MODEL TA-986 Electromedics, Inc. | FLL |
| Nov 15, 1977 | K771997 | TELETHERMOMETER MODEL T T-400 Electromedics, Inc. | FLL |
| Nov 2, 1977 | K771994 | ELECTROTHERM MODEL HT-1 Electromedics, Inc. | FLL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||