Panels › General, Plastic Surgery › Product code BTX · Class 1
Board, Arm (With Cover), Sterile
Regulation 878.3910
0510(k)s in 12 months (13 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in BTX
| Company | 510(k)s | Recalls |
|---|---|---|
| Edgewater Medical Systems, Inc. | 2 | 0 |
| Anago, Inc. | 1 | 0 |
| Datamed, Inc. | 1 | 0 |
| Fibre Formations, Inc. | 1 | 0 |
| Harvey A. Turner, M.D. | 1 | 0 |
| Infection Control Products, Inc. | 1 | 0 |
| Karlin Technology, Inc. | 1 | 0 |
| Medical Innovations Corp. | 1 | 0 |
| Precept, Inc. | 1 | 0 |
| Rick Robbin & Frederick Auerbach | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 15, 1994 | K935098 | BABY BOARD Sentry Medical Products, Inc. | BTX |
| Jan 24, 1990 | K900175 | 4/1 ARMBOARD Infection Control Products, Inc. | BTX |
| Dec 15, 1988 | K884838 | ALLEN PRONE ARMBOARD Edgewater Medical Systems, Inc. | BTX |
| Jul 8, 1988 | K882524 | UNIVERSALLY ADJUSTABLE ARMBOARD Karlin Technology, Inc. | BTX |
| Apr 7, 1988 | K881292 | ALLEN LATERAL ARMBOARD Edgewater Medical Systems, Inc. | BTX |
| Jan 12, 1987 | K864670 | BOARD, ARM (WITH COVER) Anago, Inc. | BTX |
| Dec 27, 1983 | K833664 | ARMBOARD AND THE BOARD Rick Robbin & Frederick Auerbach | BTX |
| Jan 26, 1983 | K830018 | SAFE-T ARM BOARD Harvey A. Turner, M.D. | BTX |
| Dec 15, 1982 | K823412 | ARM BOARD W/I.V COVERING Sage Products, Inc. | BTX |
| Jun 12, 1981 | K811419 | SPRIO-LOOP Datamed, Inc. | BTX |
| Dec 6, 1979 | K792147 | ARM SHIELD FOR ANESTHESIA Medical Innovations Corp. | BTX |
| Aug 14, 1978 | K781233 | IV ARMBOARDS Fibre Formations, Inc. | BTX |
| Mar 7, 1977 | K770391 | COVER, ARMBOARD, DISPOSABLE Precept, Inc. | BTX |
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