Atlas FDA

FQO

35 FDA 510(k) clearances · Product code

77 daysmedian time to decision
200 days90th percentile
35clearances measured

FDA profile

Official device name
Table, Operating-Room, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 878.4960
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 102 · 2022: 125 · 2023: 187 · 2024: 139 · 2025: 115 · 2026: 116
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Maestro System (REF100) (K240598)Moon Surgical2024-06-03
Maestro Platform (K221410)Moon Surgical2022-12-02
STERIS CMAX XLT SURGICAL TABLE (K090136)STERIS Corporation2009-03-20
OPT80 THE TRANSPORTABLE (OPT80) (K972810)O.P.T. USA, Inc.1997-08-26
ALLEN, ULTRA AND SMART SOCKETS (K971988)Allen Medical Systems, Inc.1997-07-11
AMSCO SURGICAL TABLE (K971307)STERIS Corporation1997-06-27
TENET RADIOLUCENT HAND TABLE (K963506)Tenet Medical Engineering1997-01-09
DRAGER GEMINA WALL-MOUNTED WORKPLACE (K961886)Alm Surgical Equipment, Inc.1996-07-30
DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM (K961742)Alm Surgical Equipment, Inc.1996-07-26
TELETOM (K955750)Berchtold Holding GmbH1996-02-08
KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT (K953980)Kreuzer Corp.1995-11-16
LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY (K951854)Leonard Medical, Inc.1995-06-21
SKYTRON SKYBOOM SERIES (K950192)Skytron, Div. the Kmw Group, Inc.1995-04-03
RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES (K926463)Midmark Corp.1994-10-21
IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE (K942486)Mdt Corp., Inc.1994-08-10
DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E (K942043)Alm Surgical Equipment, Inc.1994-07-13
MDT SHAMPAINE 5100B AND 5100E SURGICAL TABLES (K941150)Mdt Technology For Life1994-06-10
STRYKER OPERATING ROOM TABLE (K940068)Stryker Medical1994-05-05
ENDEX ENDOSCOPIC POSITIONING SYSTEM (K936308)Andronic Devices, Ltd.1994-03-31
BETASTAR 1131.02 MOBILE OPERATING TABLE (K926525)Stierlen-Maquet AG1993-10-12
QUANTUM 3080 SURGICAL TABLE (K930493)American Sterilizer Co.1993-06-22
BYPASS LEG POSITIONER (K932186)Voss Medical Products1993-06-01
FISK HEADREST (K924700)Rhino Mfg.1993-01-15
DRAGER DVE 4000 SERIES SYSTEM (K921297)Alm Surgical Equipment, Inc.1992-11-27
PNEUMO-WEDGE (K921143)Kansas Creative Devices, Inc.1992-09-11
OPERATING TABLE SYSTEM-BETAMAQUET 1140 (K920890)Stierlen-Maquet AG1992-07-02
SPINAL POSITIONING FRAME (K922371)Rhino Mfg.1992-06-04
TELETOM(R) (K921626)Berchtold Holding GmbH1992-05-05
712 PLASTIC SURGERY TABLE & ACCESORIES (K915141)Midmark Corp.1992-01-09
GENERAL SURGICAL TABLE AND ACCESSORIES (K882660)American Sterilizer Co.1988-07-25
ARTHROBOT(TM) LOWER LIMB POSITIONER (K880227)Andronic Devices, Ltd.1988-02-18
DR.500O OPERATING TABLE (K864295)Koken Mfg Company, Inc.1986-11-19
DR7700 OPERATING TABLE (K864325)Koken Mfg Company, Inc.1986-11-19
CHARLES/MCINTYRE GIANT BREAK TABLE (K841115)Surgi-Quip Inc.U1984-05-09
CEILING MOUNTED SUPPORT (K831086)Amsco Co.1983-08-12

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