Atlas FDA

GAD

100 FDA 510(k) clearances · Product code

36 daysmedian time to decision
182 days90th percentile
100clearances measured

FDA profile

Official device name
Retractor
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 81 · 2022: 80 · 2023: 80 · 2024: 111 · 2025: 107 · 2026: 48
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
JRP Wound Spreader (K152538)J.R. Parker, LLC2016-04-13
OTELO LL (K151104)Spineart2016-01-06
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES (K132645)Medtronic, Inc.2013-10-04
DASH (K071775)Ezsurgical2007-08-07
APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (K050256)Apple Medical Corp.2005-04-26
QUADRANT RETRACTOR SYSTEM (K043602)Medtronic Sofamor Danek2005-02-23
MRI FASTSYSTEM RETRACTOR SYSTEM (K001339)Omni-Tract Surgical, Div. Minn. Scientific, Inc.2000-05-17
CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (K980588)Clarus Medical Systems, Inc.1998-08-18
SCION SAPHENOUS VEIN HARVESTING SYSTEM (K963006)Scion International, Inc.1996-09-20
VILLALTA RETRACTOR (K943875)Hct, Inc.1994-11-09
RETRACTOR (K942002)Automated Medical Products Corp.1994-05-17
RETRACTOR (K941448)Technovations1994-04-15
LUNG RETRACTORS: DAVIDSON, SEMB (K930316)Thomasville Medical Assoc.1994-02-10
THOROCOSCOPY SELF-RETAINING RETRACTOR (K926585)T. Korossurgical Instruments Corp.1993-08-06
HARGIS SELF RETRACTION SYSTEM (K921020)Medin Corp.1993-07-02
HARGIS SR2 SELF-RETRACTION SYSTEM (K921017)Medin Corp.1993-07-02
HARGIS RECTAL SELF RETRATION SYSTEM (K921019)Medin Corp.1993-07-02
ADEPT INSTRUMENT POSITIONING ACCESSORY (K922626)Andronic Devices, Ltd.1992-10-19
ADEPT ENDOSCOPIC POSITIONER (K922625)Andronic Devices, Ltd.1992-10-19
LEVY ARTICULATING RETRACTOR (K920471)Lifeguard Medical Products, Inc.1992-06-23
AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR (K914190)United States Surgical, A Division of Tyco Healthc1992-05-06
REDDICK RETRACTOR (K915175)Ideal Medical, Inc.1992-04-29
SUREBREATH DOME, E-Z BREATHER (K915158)Ipax, Inc.1992-02-12
TEKDYNE MICRO RETRACTOR (K910975)Tekdyne1991-04-01
SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET (K903969)Karlin Technology, Inc.1990-09-05
GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) (K893869)Adept-Med Intl., Inc.1989-08-03
GOOTT BALFOUR BLADE (K893871)Adept-Med Intl., Inc.1989-08-03
ROBOTRAC (TM) RETRACTOR ARM (K893121)Aesculap Instruments Corp.1989-06-01
ROLLET RETRACTOR (K891892)Zinnanti Surgical Instruments, Inc.1989-04-12
KIRSCHNER RETRACTOR (K891031)Zinnanti Surgical Instruments, Inc.1989-04-06
LOCKING WIRE GUIDE STYLET (K890820)Medical Engineering and Development Institute1989-03-22
SURGICAL WIRE CUTTERS (K890250)Kinetic Medical Products1989-01-27
SURGICAL RETRACTORS (K890248)Kinetic Medical Products1989-01-27
SURGICAL RETRACTORS (K890247)Kinetic Medical Products1989-01-27
SUREBREATH DOME (K884076)Ipax, Inc.1988-10-07
SUCTION RETRACTORS (K882074)Karlin Technology, Inc.1988-06-16
SELF-RETAINING SOFT TISSUE RETRACTOR (K882075)Karlin Technology, Inc.1988-06-16
MURSE RETRACTOR (K882112)Euro-American Marketing Group, Inc.1988-06-15
STERNUM SPREADER AND MITRAL VALVE RETRACTOR (K881157)T. Korossurgical Instruments Corp.1988-04-06
I.M.A. RETRACTOR (K881159)T. Korossurgical Instruments Corp.1988-04-05
UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR (K881156)T. Korossurgical Instruments Corp.1988-04-05
STERNUM SPREADER, PEDIATRIC (K880998)T. Korossurgical Instruments Corp.1988-03-21
SPRING RETRACTOR (K880997)T. Korossurgical Instruments Corp.1988-03-21
SELF-RETAINING SOFT TISSUE RETRACTOR (K880813)T. Korossurgical Instruments Corp.1988-03-11
HIP, FEMUR AND HUMERUS RETRACTOR (K880151)Twenty-First Century Orthopedics, Inc.1988-02-18
SUCTION RETRACTOR (K875289)T. Korossurgical Instruments Corp.1988-01-22
ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000 (K874243)Pilling Co.1987-11-13
OMNI-TRACT CORRAL RETRACTOR (K872919)Minnesota Scientific, Inc.1987-08-11
STERI-TRACTOR WOUND RETRACTOR (K870543)3M Company1987-02-24
RAYLOR(TM) PROTECTIVE RETRACTOR (K864424)Cedar Surgical, Inc.1986-11-26
LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS (K864384)Luxtec Corp.1986-11-19
VARIOUS SURGICAL INSTRUMENTS (K862597)Konig W.G., Ltd.1986-07-23
OMNI-TRACT CHEST WALL & LUNA RETRACTOR (K853947)Minnesota Scientific, Inc.1985-10-16
RAYLOR RETRACTORS (K853796)Cedar Surgical, Inc.1985-10-07
ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR (K853114)Australian Biomedical Corporation , Ltd.1985-08-06
TITANIUM PROBES (K852415)L.A.S.E.R., Inc.1985-08-02
3M FUKUDA TYPE RING RETRACTOR (K852567)3M Company1985-07-09
WEITIANER MASTOID 3 VS 4 BLUNT & SHARP PRONGS (K852530)The Huxley Instrument Corp.1985-06-28
RETRACTOR, SURGICAL (K852330)Scholten Surgical Instruments, Inc.1985-06-27
21-450 GELPI RETRACTOR (K851776)Artiberia1985-06-20
VOLKMAN RETRACTOR 699-576 PCS. SHARP-4 PRONGS SS42 (K851108)The Huxley Instrument Corp.1985-04-25
FINOCCHIETO RIB RETRACTOR 1711-72 PCS. SS 303, 420 (K851115)The Huxley Instrument Corp.1985-04-25
COSGROVE MITRAL VALVE RETRACTOR (K844177)Kapp Surgical Instrument, Inc.1984-11-08
INSTRUMENTS FOR MICRO ANASTOMOSIS (K843100)Downs Surgical , Ltd.1984-09-27
ECLIPSE HEART SUPPORT FOR CORONARY ARTER (K843216)Biotrac Laboratories1984-09-20
HOOK (K841625)Plastafil, Inc.1984-08-27
GRASSHOPPER - RETRACTOR (K842992)Norton Texas Medical Products1984-08-17
OMNI-TRACT SURGICAL RETRACTOR SYS (K842762)Minnesota Scientific, Inc.1984-08-17
SURGICAL RETRACTORS-VARIOUS (K841009)Premier Dental Products Co.1984-05-01
ADHESIVE TRACTION TAPE (K834142)Devon Industries, Inc.1984-04-23
JAKOBI SURG. INSTRUMENTS #11 20/25/27/37 (K834196)Imm Enterprises , Ltd.1984-01-27
FLEXI-TY (K832765)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-01-27
H.R. JAKOBI SURG. INSTRUMENTS #11 16/46 (K834181)Imm Enterprises , Ltd.1984-01-27
SURGICAL INSTRUMENT (K833541)Hirata Sangyo Co. USA, Inc.1983-11-28
ANVIL RETRACTOR (K830585)Twin City Surgical, Inc.1983-05-27
ZIMMER SKIN PROTECTOR (K830287)Zimmer, Inc.1983-03-09
PILLING IDENTI-LOOPS (K820377)Narco Scientific1982-03-10
SELF RETAINING RETRACTOR FOR HAND SURG (K820290)The Anspach Effort, Inc.1982-03-05
SURGICAL LOOPS (K812875)M-W Laboratories, Inc.1981-11-20
SURGICAL LOOPS (K812389)Berkeley Medevices1981-11-16
RETRACTING PROBES (K811759)American V. Mueller1981-07-20
ARTHROSCOPIC FAT PAD RETRACTOR (K802599)The Anspach Effort, Inc.1980-10-31
ETHICON RETRACTION TAPE (K801699)ETHICON, Inc.1980-09-26
EFFRON PAROTID RETRACTOR (K801759)American V. Mueller1980-08-20
DEEP BALFOUR BLADE FOR WILKINSON RETRACT (K801611)Edward Weck, Inc.1980-08-04
AUTOMATIC RETRACTOR HOLDERS (K792145)Automated Medical Products, Inc.1979-12-05
SPREADER (K781445)Orthopedic Equipment Co., Inc.1979-09-27
SCOTTS SURGICAL RETRACTOR AND ELASTIC (K791665)Lone Star Medical Products, Inc.1979-09-19
TISSURE RETRACTORS (K791122)Xomed, Inc.1979-07-10
CLAMP COVERS (K790952)Medi-Spec1979-06-05
IDENTI-LOOPS (K780720)Berkeley Bio-Medical, Inc.1978-10-17
ULTRASOUND IMAGING SYSTEM (K780993)Boehringer Mannheim Corp.1978-08-10
AUTOMATIC RETRACTOR HOLDER (K780708)Great Eastern Lumber Co., Inc.1978-07-17
NEIVS TRACHEOTOMY RETRACTOR (K772378)Edward Weck, Inc.1978-03-09
HEISS RETRACTOR (K771191)Edward Weck, Inc.1977-07-11
PROBE RETRACTOR, PART #S-2L8-6 (K770414)Acme United Corp.1977-04-15
RETRACTORS & HOOKS, ABRAMSON (K770651)Edward Weck, Inc.1977-04-14
RETRACTOR, SKIN HOOK (K770418)Acme United Corp.1977-03-23
VANDERBILT PITUITARY RETRACTOR (K761096)Codman & Shurtleff, Inc.1976-11-30
SURGICAL RETRACTOR (K760422)Cutter Laboratories, Inc.1976-08-23

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