Axiom Medical, Inc.
Torrance, CA, US
AXIOM MEDICAL, INC. appears in FDA device records in Torrance, CA. FDA records list 28 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 28 510(k) clearances for Axiom Medical, Inc. between 1977 and 2000. The busiest year on record is 1977, with 4. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 4 |
| 1978 | 1 |
| 1979 | 2 |
| 1980 | 1 |
| 1982 | 1 |
| 1983 | 4 |
| 1984 | 3 |
| 1985 | 2 |
| 1986 | 2 |
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 1 |
| 1994 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K993592 | AXIOM MULTIPURPOSE WOUND DRAIN | BSO | Substantially Equivalent | |
| K971851 | INTERPLEURAL ANESTHESIA CATHETER | BSO | Substantially Equivalent | |
| K965146 | FLAT CLOSED WOUND DRAIN WITH TROCAR | GBX | Substantially Equivalent | |
| K934895 | GLASSMAN SILICONE CATHETER | EZL | Substantially Equivalent | |
| K922760 | ATRAUM WOUND DRESSING--MODIFICATION | KMF | Substantially Equivalent | |
| K905422 | PVC ROUND WOUND DRAINS | GBX | Substantially Equivalent | |
| K904218 | SUCTION SYSTEM | GEA | Substantially Equivalent | |
| K904133 | DISPOSABLE FLUID COLLECTION BAG | GBX | Substantially Equivalent | |
| K863247 | AXIOM TROCAR THORACIC CATHETER | GBS | Substantially Equivalent | |
| K861306 | SUCTION SYSTEM | GEA | Substantially Equivalent | |
| K852614 | ATRAUM WOUND DRESSING | FRO | Substantially Equivalent | |
| K852241 | AXIOM ATRAUM TROCAR CATHETER | GBS | Substantially Equivalent | |
| K841574 | QUAZAR ESOPHAGEAL STETHOSCOPE | BZW | Substantially Equivalent | |
| K842084 | AXIOM FEMORAL VENUS CATHETER | DQY | Substantially Equivalent | |
| K841593 | AXIOM THORACIC CATHETERS | Substantially Equivalent | ||
| K832476 | SILICONE SOFT-PAK EPISTAXIS CATHETER | ENW | Substantially Equivalent | |
| K832416 | AXIOM HYDROMER WOUND DRAINS | GBS | Substantially Equivalent | |
| K832475 | AXIOM PERFUSSION CANNULA | DWF | Substantially Equivalent | |
| K831823 | AXIOM FEEDING GASTRO TUBE | KNT | Substantially Equivalent | |
| K820161 | AXIOM LIG-A-BOOTS | KDC | Substantially Equivalent | |
| K800015 | AXIOM VESSEL LOOPS | KDC | Substantially Equivalent | |
| K791509 | AXIOM GASTRO SUMP DRAIN | Substantially Equivalent | ||
| K791508 | AXIOM FILTERED CONNECTOR | Substantially Equivalent | ||
| K781749 | TUBING, AXIOM SILICONE PENROSE | KDH | Substantially Equivalent | |
| K771022 | CATHETER, UMBILICAR ARTERY | FOS | Substantially Equivalent | |
| K770983 | CATHETER THORACIC, AXIOM | JOL | Substantially Equivalent | |
| K771048 | CATHETERS, DRAINAGE | FEG | Substantially Equivalent | |
| K771021 | AUTO-CLIP | DSS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2020735 | 2020735 | AXIOM MEDICAL, INC. | 19320 SOUTH VAN NESS AVE., TORRANCE, CA 90501 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- KMFBandage, Liquid
- KDQBottle, Collection, Vacuum
- GEACannula, Surgical, General & Plastic Surgery
- KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
- JOLCatheter And Tip, Suction
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- BSOCatheter, Conduction, Anesthetic
- GBXCatheter, Irrigation
- ENWCatheter, Nasopharyngeal
- DQYCatheter, Percutaneous
- EZLCatheter, Retention Type, Balloon
- FOSCatheter, Umbilical Artery
- GBSCatheter, Ventricular, General & Plastic Surgery
- DSSClip, Vascular
- FRODressing, Wound, Drug
- KDCInstrument, Surgical, Disposable
- BZWStethoscope, Esophageal
- FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation
- KNTTubes, Gastrointestinal (And Accessories)
- GAZTubing, Noninvasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain