Company ยท US
Axiom Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2000. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GBS | Catheter, Ventricular, General & Plastic Surgery | 3 |
| GBX | Catheter, Irrigation | 3 |
| BSO | Catheter, Conduction, Anesthetic | 2 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 2 |
| KDC | Instrument, Surgical, Disposable | 2 |
| BZW | Stethoscope, Esophageal | 1 |
| DQY | Catheter, Percutaneous | 1 |
| DSS | Clip, Vascular | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| ENW | Catheter, Nasopharyngeal | 1 |
| EZL | Catheter, Retention Type, Balloon | 1 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | 1 |
| FOS | Catheter, Umbilical Artery | 1 |
| FRO | Dressing, Wound, Drug | 1 |
| JOL | Catheter And Tip, Suction | 1 |
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | 1 |
| KMF | Bandage, Liquid | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 17, 2000 | K993592 | AXIOM MULTIPURPOSE WOUND DRAIN Axiom Medical, Inc. | BSO |
| Jan 22, 1998 | K971851 | INTERPLEURAL ANESTHESIA CATHETER Axiom Medical, Inc. | BSO |
| Mar 10, 1997 | K965146 | FLAT CLOSED WOUND DRAIN WITH TROCAR Axiom Medical, Inc. | GBX |
| Oct 13, 1994 | K934895 | GLASSMAN SILICONE CATHETER Axiom Medical, Inc. | EZL |
| Oct 30, 1992 | K922760 | ATRAUM WOUND DRESSING--MODIFICATION Axiom Medical, Inc. | KMF |
| Feb 11, 1991 | K905422 | PVC ROUND WOUND DRAINS Axiom Medical, Inc. | GBX |
| Oct 31, 1990 | K904218 | SUCTION SYSTEM Axiom Medical, Inc. | GEA |
| Oct 11, 1990 | K904133 | DISPOSABLE FLUID COLLECTION BAG Axiom Medical, Inc. | GBX |
| Aug 29, 1986 | K863247 | AXIOM TROCAR THORACIC CATHETER Axiom Medical, Inc. | GBS |
| Jun 9, 1986 | K861306 | SUCTION SYSTEM Axiom Medical, Inc. | GEA |
| Aug 30, 1985 | K852614 | ATRAUM WOUND DRESSING Axiom Medical, Inc. | FRO |
| Jun 14, 1985 | K852241 | AXIOM ATRAUM TROCAR CATHETER Axiom Medical, Inc. | GBS |
| Aug 15, 1984 | K841574 | QUAZAR ESOPHAGEAL STETHOSCOPE Axiom Medical, Inc. | BZW |
| Aug 1, 1984 | K842084 | AXIOM FEMORAL VENUS CATHETER Axiom Medical, Inc. | DQY |
| Jun 5, 1984 | K841593 | AXIOM THORACIC CATHETERS Axiom Medical, Inc. | |
| Nov 3, 1983 | K832476 | SILICONE SOFT-PAK EPISTAXIS CATHETER Axiom Medical, Inc. | ENW |
| Oct 31, 1983 | K832416 | AXIOM HYDROMER WOUND DRAINS Axiom Medical, Inc. | GBS |
| Oct 19, 1983 | K832475 | AXIOM PERFUSSION CANNULA Axiom Medical, Inc. | DWF |
| Aug 12, 1983 | K831823 | AXIOM FEEDING GASTRO TUBE Axiom Medical, Inc. | KNT |
| Mar 15, 1982 | K820161 | AXIOM LIG-A-BOOTS Axiom Medical, Inc. | KDC |
| Mar 25, 1980 | K800015 | AXIOM VESSEL LOOPS Axiom Medical, Inc. | KDC |
| Sep 4, 1979 | K791509 | AXIOM GASTRO SUMP DRAIN Axiom Medical, Inc. | |
| Sep 4, 1979 | K791508 | AXIOM FILTERED CONNECTOR Axiom Medical, Inc. | |
| Dec 4, 1978 | K781749 | TUBING, AXIOM SILICONE PENROSE Axiom Medical, Inc. | KDH |
| Nov 29, 1977 | K771022 | CATHETER, UMBILICAR ARTERY Axiom Medical, Inc. | FOS |
| Jul 29, 1977 | K770983 | CATHETER THORACIC, AXIOM Axiom Medical, Inc. | JOL |
| Jul 19, 1977 | K771048 | CATHETERS, DRAINAGE Axiom Medical, Inc. | FEG |
| Jun 14, 1977 | K771021 | AUTO-CLIP Axiom Medical, Inc. | DSS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||