Panels › General, Plastic Surgery › Product code BWN · Class 1
Table And Attachments, Operating-Room
Regulation 878.4950
0510(k)s in 12 months (20 all time)
1recalls in 12 months (75 all time)
69recalls that name a 510(k)
Top companies in BWN
| Company | 510(k)s | Recalls |
|---|---|---|
| The Anspach Effort, Inc. | 1 | 72 |
| Northwest Surgical Concepts, Inc. | 2 | 0 |
| Alpha Surgical, Inc. | 1 | 0 |
| American Sterilizer Co. | 1 | 0 |
| David Simmonds Co., Inc. | 1 | 0 |
| Dyonics, Inc. | 1 | 0 |
| Edgewater Medical Equipment Systems | 1 | 0 |
| Ets Rene Marzet | 1 | 0 |
| Infinitech, Inc. | 1 | 0 |
| Innovative Orthopedic Technologies, LLC | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 13, 1994 | K942699 | AIRFRAME SURGICAL DRAPE SUPPORT Alpha Surgical, Inc. | BWN |
| Feb 7, 1994 | K935441 | INFINITECH BREATH EZ Infinitech, Inc. | BWN |
| Apr 29, 1993 | K925005 | ISI SELF-SUPPORTING ARM Instrumentation Specialties, Inc. | BWN |
| Feb 10, 1993 | K922288 | HOLDER, PEDIATRIC POSITION Yamashita and Hemsley Business Trust | BWN |
| Apr 2, 1991 | K910783 | SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M Smith & Nephew Equipment Group | BWN |
| Sep 10, 1990 | K902865 | BAUMER SURGICAL TABLE Sds Dental, Inc. | BWN |
| Nov 17, 1988 | K884558 | IOP ADJUSTABLE STIRRUP Mend Technologies, Inc. | BWN |
| Jan 22, 1988 | K875291 | SPINAL SURGERY FRAME T. Korossurgical Instruments Corp. | BWN |
| Sep 8, 1987 | K873272 | ENDOSCOPY TABLE 1532 ENDOSTAR Stierlen-Maquet AG, GR | BWN |
| Feb 11, 1986 | K860177 | ALLEN UNIVERSAL STIRRUP Edgewater Medical Equipment Systems | BWN |
| Jul 2, 1985 | K852332 | TABLE ACCESSORIES, OPERATING ROOM Scholten Surgical Instruments, Inc. | BWN |
| Sep 7, 1984 | K843121 | GUIDE TO THE KNEE Dyonics, Inc. | BWN |
| Aug 12, 1983 | K832340 | OPERATING ROOM TABLES HYDRAULIC Kamiya Tsusan Kaisha, Ltd. | BWN |
| Jan 14, 1983 | K823772 | AMSCO ORTHOGRAPHIC 2 TABLE American Sterilizer Co. | BWN |
| Mar 23, 1982 | K820574 | ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL David Simmonds Co., Inc. | BWN |
| Nov 20, 1981 | K812396 | ARTHRO-PREP REST Northwest Surgical Concepts, Inc. | BWN |
| Nov 20, 1981 | K812395 | ARTHRO-PREP REST W/STAND Northwest Surgical Concepts, Inc. | BWN |
| Oct 23, 1980 | K802271 | THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC The Anspach Effort, Inc. | BWN |
| Jan 4, 1980 | K792569 | OPERATING TABLES & AMPLINOX 03 Ets Rene Marzet | BWN |
| Oct 4, 1979 | K791859 | TECNOL STIRRUPS STRAP Tecnol New Jersey Wound Care, Inc. | BWN |
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