Atlas FDA

GDC

18 FDA 510(k) clearances · Product code

29 daysmedian time to decision
119 days90th percentile
18clearances measured

FDA profile

Official device name
Table, Operating-Room, Electrical
Device class
Class I (low risk)
Regulation
21 CFR 878.4960
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 259 · 2022: 57 · 2023: 62 · 2024: 91 · 2025: 101 · 2026: 52
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
QUANTUM 3080SP SURGICAL TABLE (K971390)STERIS Corporation1997-05-15
MOBILE OPERATING TABLE 1132.01 (K970807)Stierlen-Maquet AG1997-03-14
DURA-BOARD ARMBOARD (K964273)Allen Medical Systems, Inc.1997-01-08
SKYTRON ELITE 3500 TABLE (K940616)Skytron, Div. the Kmw Group, Inc.1994-06-13
MIDMARK MAGNUM GENERAL SURGICAL TABLE (K934744)Midmark Corp.1994-03-28
MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE (K914758)Mdt Corp., Inc.1991-12-19
MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE (K915393)Mdt Corp., Inc.1991-12-17
OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. (K883613)Stierlen-Maquet AG1988-09-15
MOBILE OPERATING TABLE FOR ORL MICROSURGERY (K853720)Carl Zeiss, Inc.1985-10-18
SKYTRON ELITE 6000 & 6001 SURGICAL TABLES (K853480)Skytron, Div. the Kmw Group, Inc.1985-09-12
TRAUMA TABLE (K853535)Xre Corp.1985-09-11
MAYFIELD TABLE-ELECTRIC (K851021)Ohio Medical Instrument Co., Inc.1985-05-21
SKYTRON ELITE 7000 MICRO-SURGERY TABLE (K851830)Skytron, Div. the Kmw Group, Inc.1985-05-17
SKYTRON ELITE 3100 SURGICAL TABLE (K851829)Skytron, Div. the Kmw Group, Inc.1985-05-17
STILLE SCANDIA OPERATING TABLES RC 3000,1100 (K850168)Stille-Werner (Usa), Inc.1985-03-28
MOBILE OPERATING TABLE HEIDELBERGS 1130 (K843134)Stierlen-Maquet AG1984-09-07
AMSCO ENDOSCOPY TABLE (K821749)American Sterilizer Co.1982-07-09
PEDESTAL EXAMINING TABLE (K821665)American Hamilton1982-06-24

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Every clearance here is in the API, with alerts when new ones post.