Company ยท US
Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2008. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 4 |
| JOD | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass | 4 |
| FJG | Dialyzer, Parallel Flow | 3 |
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 3 |
| CAK | Microfilter, Blood Transfusion | 2 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 2 |
| BZC | Calculator, Pulmonary Function Data | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 |
| FPB | Filter, Infusion Line | 1 |
| GEE | Brush, Biopsy, General & Plastic Surgery | 1 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 1 |
| QKP | Coronavirus Antigen Detection Test System. | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 8, 2008 | K082311 | EXSUDEX WOUND DRAINAGE PUMP The Medical Company, NL | OMP |
| Jun 22, 1993 | K926454 | ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON Medical, Inc. | CAI |
| Oct 24, 1989 | K894839 | OS-1 OCCLUSION SYSTEM - 1 Medical, Inc. | BZC |
| Jun 15, 1987 | K872001 | MODEL TPC-1A OXYGEN ANALYZER Medical, Inc. | CCL |
| Oct 15, 1986 | K863806 | MODEL A-1 OXYGEN ANALYZER Medical, Inc. | CCL |
| Sep 4, 1986 | K862609 | INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 Medical, Inc. | DTM |
| Sep 4, 1986 | K862591 | INTERFACE ARTERIAL BLOOD FILTER, MODEL 42 Medical, Inc. | DTM |
| Jun 2, 1986 | K861226 | INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 Medical, Inc. | KRJ |
| Oct 18, 1985 | K854003 | STERILE SOFT TISSUE BIOPSY NEEDLE Co-Medical, Inc. | GEE |
| Oct 8, 1985 | K853623 | CHIBA, MADAYAG, POTTS-COURNAND, SELDINGER BIOPSY N Co-Medical, Inc. | |
| Jun 27, 1985 | K851370 | INTERFACE TRANSFUSION BLOOD FILTER #35 Medical, Inc. | CAK |
| Jan 7, 1983 | K823261 | INTERFACE TRANSFUSION BLOOD FILTER #30 Medical, Inc. | CAK |
| Nov 24, 1982 | K823260 | INTERFACE CARDIOTOMY BLOOD FILTER #51 Medical, Inc. | JOD |
| Nov 24, 1982 | K823259 | INTERFACE CARDIOTOMY BLOOD FILTER #50 Medical, Inc. | JOD |
| Nov 24, 1982 | K823258 | INTERFACE ARTERIAL BLOOD FILTER #40 Medical, Inc. | DTM |
| Nov 27, 1981 | K813131 | INTERFACE ARTERIAL BLOOD FILTER Medical, Inc. | DTM |
| Aug 25, 1981 | K812244 | INTERFACE PRE BYPASS PRIME FILTER #90 Medical, Inc. | KRJ |
| Aug 25, 1981 | K812243 | INTERFACE CARDIOTOMY BLOOD FILTER #51 Medical, Inc. | JOD |
| Aug 25, 1981 | K812240 | INTERFACE PRE BYPASS PRIME FILTER Medical, Inc. | KRJ |
| Sep 26, 1980 | K801451 | ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM Medical, Inc. | FJG |
| May 8, 1979 | K790758 | HEMOCLEAR U-NEPHROS 1.0 DIALYZER Medical, Inc. | FJG |
| Dec 15, 1978 | K781795 | DIALYZER, PARALLEL FLOW DISPOSABLE Medical, Inc. | FJG |
| Sep 27, 1978 | K781383 | INTERFACE CARDIOTOMY BLOOD FILTER Medical, Inc. | JOD |
| Oct 13, 1977 | K771862 | TRANSFUSION BLOOD FILTER Medical, Inc. | FPB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2022 | USA Medical, LLC Diagnostic Kit SARS-cCo V Antigen Rapid Test Open, Classified |
QKP | None listed |