BWN
20 FDA 510(k) clearances · Product code
32 daysmedian time to decision
209 days90th percentile
20clearances measured
FDA profile
- Official device name
- Table And Attachments, Operating-Room
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2009: 3 · 2012: 7 · 2013: 6 · 2021: 16 · 2023: 50 · 2024: 51
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AIRFRAME SURGICAL DRAPE SUPPORT (K942699) | Alpha Surgical, Inc. | 1994-07-13 |
| INFINITECH BREATH EZ (K935441) | Infinitech, Inc. | 1994-02-07 |
| ISI SELF-SUPPORTING ARM (K925005) | Instrumentation Specialties, Inc. | 1993-04-29 |
| HOLDER, PEDIATRIC POSITION (K922288) | Yamashita and Hemsley Business Trust | 1993-02-10 |
| SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M (K910783) | Smith & Nephew Equipment Group | 1991-04-02 |
| BAUMER SURGICAL TABLE (K902865) | Sds Dental, Inc. | 1990-09-10 |
| IOP ADJUSTABLE STIRRUP (K884558) | Mend Technologies, Inc. | 1988-11-17 |
| SPINAL SURGERY FRAME (K875291) | T. Korossurgical Instruments Corp. | 1988-01-22 |
| ENDOSCOPY TABLE 1532 ENDOSTAR (K873272) | Stierlen-Maquet AG | 1987-09-08 |
| ALLEN UNIVERSAL STIRRUP (K860177) | Edgewater Medical Equipment Systems | 1986-02-11 |
| TABLE ACCESSORIES, OPERATING ROOM (K852332) | Scholten Surgical Instruments, Inc. | 1985-07-02 |
| GUIDE TO THE KNEE (K843121) | Dyonics, Inc. | 1984-09-07 |
| OPERATING ROOM TABLES HYDRAULIC (K832340) | Kamiya Tsusan Kaisha, Ltd. | 1983-08-12 |
| AMSCO ORTHOGRAPHIC 2 TABLE (K823772) | American Sterilizer Co. | 1983-01-14 |
| ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL (K820574) | David Simmonds Co., Inc. | 1982-03-23 |
| ARTHRO-PREP REST (K812396) | Northwest Surgical Concepts, Inc. | 1981-11-20 |
| ARTHRO-PREP REST W/STAND (K812395) | Northwest Surgical Concepts, Inc. | 1981-11-20 |
| THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC (K802271) | The Anspach Effort, Inc. | 1980-10-23 |
| OPERATING TABLES & AMPLINOX 03 (K792569) | Ets Rene Marzet | 1980-01-04 |
| TECNOL STIRRUPS STRAP (K791859) | Tecnol New Jersey Wound Care, Inc. | 1979-10-04 |
Track BWN automatically
Every clearance here is in the API, with alerts when new ones post.