Company ยท US
Axiom, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2003. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ITH | Equipment, Traction, Powered | 2 |
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| GBS | Catheter, Ventricular, General & Plastic Surgery | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 25, 2003 | K033015 | AXIOM BIOLASER LLLT SERIES-3 Axiom Usa., Inc. | NHN |
| Sep 9, 2003 | K030622 | AXIOM BIOLASER LLLT SERIES-1 Axiom Usa., Inc. | NHN |
| Jan 23, 2003 | K022602 | DRX3000 Axiom Usa., Inc. | ITH |
| Dec 20, 2002 | K023160 | DRX5000 Axiom Usa., Inc. | ITH |
| Feb 17, 1989 | K883887 | AXIOM ATRAUM WOUND DRAINS Axiom, Inc. | GBS |
| Sep 13, 1984 | K842443 | AXIOM STABLE II TRIGLYCERIDES TEST Axiom, Inc. | CDT |
| Aug 16, 1984 | K842442 | AXIOM STABLE II URIC ACID TEST Axiom, Inc. | KNK |
| Jul 25, 1984 | K842441 | AXIOM STABLE II CHOLESTEROL TEST Axiom, Inc. | CHH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||