Company ยท US
American Omni Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1993. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DWD | Suction Control, Intracardiac, Cardiopulmonary Bypass | 3 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 2 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 2 |
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 2 |
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 |
| CAC | Apparatus, Autotransfusion | 1 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| DXS | Gauge, Pressure, Coronary, Cardiopulmonary Bypass | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 8, 1993 | K922781 | FLOW CONROL VALVE American Omni Medical, Inc. | MJJ |
| Feb 12, 1993 | K922356 | FLOW CONTROL VALVE, CAT. NO. ACV-38 American Omni Medical, Inc. | MJJ |
| Apr 3, 1990 | K900672 | PREBYPASS FILTER, CAT. NO. FPB-5 American Omni Medical, Inc. | KRJ |
| Jan 30, 1989 | K884893 | CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 American Omni Medical, Inc. | KRI |
| Jan 24, 1989 | K884640 | CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 American Omni Medical, Inc. | KRI |
| Jul 14, 1988 | K873316 | BUBBLE TRAP-FILTER CAT. NO B180F37 American Omni Medical, Inc. | DTM |
| Feb 29, 1988 | K875080 | AIR VENT LINE CAT. NO. AVL-36 American Omni Medical, Inc. | DTM |
| Nov 6, 1987 | K873802 | PRESSURE BARRIER KIT CAT. NO. PBK-3 American Omni Medical, Inc. | DXS |
| Nov 5, 1987 | K873610 | PEDIATRIC BUBBLE TRAP CAT. NO. B-100 American Omni Medical, Inc. | BSY |
| Oct 7, 1987 | K873488 | SILENT GUARD CAT. NO. SG-10 American Omni Medical, Inc. | DTL |
| Sep 16, 1987 | K871632 | NASOGASTRIC VOICETUBE American Omni Medical, Inc. | BTR |
| Jun 8, 1987 | K871350 | PREBYPASS FILTER American Omni Medical, Inc. | KRJ |
| Jun 8, 1987 | K870819 | BUBBLE TRAP CAT. NO. B-180 American Omni Medical, Inc. | DWF |
| Jan 6, 1987 | K864503 | MODIFIED RLV-2100 B American Omni Medical, Inc. | DWD |
| Oct 30, 1986 | K862950 | WHITE-SIPOSS TUBE, CAT NO WS-1 American Omni Medical, Inc. | BTR |
| Jun 26, 1986 | K861428 | SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 American Omni Medical, Inc. | DWD |
| Dec 27, 1985 | K852178 | EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS American Omni Medical, Inc. | CAC |
| Oct 21, 1985 | K852407 | SENSOR TAPE CAT. NO. ST-45 American Omni Medical, Inc. | DTW |
| Aug 5, 1985 | K851465 | SILENT GUARD CAT. NO. SG-30 American Omni Medical, Inc. | DTL |
| Aug 5, 1985 | K851406 | AJDJUSTABLE SUCTION CONTROL VALVE American Omni Medical, Inc. | DWD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||