FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
134377–134400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1988
GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER
K883589 · FJI
Gambro, Inc.
Gastroenterology & Urology · 38d
Cleared Sep 29, 1988
LECTROSPIRAL
K883612 · FPA
Vygon Corp.
General Hospital · 38d
Cleared Sep 29, 1988
FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE
K883856 · HBI
Advanced Surgical Products, Inc.
General & Plastic Surgery · 16d
Cleared Sep 29, 1988
FIBEROPTIC WIRE PICK LIGHTPIPE
K883857 · HBI
Advanced Surgical Products, Inc.
General & Plastic Surgery · 16d
Cleared Sep 29, 1988
FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE
K883858 · HBI
Advanced Surgical Products, Inc.
General & Plastic Surgery · 16d
Cleared Sep 29, 1988
MODIFIED TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER
K883950 · CCK
Fenem, Inc.
Anesthesiology · 21d
Cleared Sep 28, 1988
TENSTAR
K874818 · GZJ
Healthcheck Corp.
Neurology · 309d
Cleared Sep 28, 1988
VASCUCARE ANGIOPUMP
K881780 · DWB
Vascucare, Inc.
Cardiovascular · 155d
Cleared Sep 28, 1988
MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH
K881825 · DYB
Spectramed, Inc.
Cardiovascular · 152d
Cleared Sep 28, 1988
ACS SCHWARTEN XT BALLOON DILATATION CATHETER
K882925 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 77d
Cleared Sep 28, 1988
ACS ANGIOSCOPE GUIDE WIRE
K883000 · LYK
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 72d
Cleared Sep 28, 1988
4000/4900/6000/8000/8900 ND:YAG/1700 ND:YAG C02
K883089 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 69d
Cleared Sep 28, 1988
TEN20 CONDUCTIVE
K883149 · GYB
Weaver & Co.
Neurology · 64d
Cleared Sep 28, 1988
SARNS INFANT VENOUS RESERVOIR MODEL #16387
K883345 · DTN
3M Health Care, Sarns
Cardiovascular · 50d
Cleared Sep 28, 1988
STERILIZATION WRAP TYPE 22,44,77
K883376 · FRG
East Texas Lighthouse For the Blind
General Hospital · 50d
Cleared Sep 28, 1988
LINDSTROM CORDLESS EPILATOR
K883429 · KCW
A Place of Health & Beauty
General & Plastic Surgery · 44d
Cleared Sep 28, 1988
HERPES VIRUS CONTROL SLIDES
K883684 · GQN
Val Tech Diagnostics, Inc.
Microbiology · 30d
Cleared Sep 28, 1988
IMMUNO/FEBRILE ANTIGENS
K883685 · GNC
Immunostics Co., Inc.
Microbiology · 30d
Cleared Sep 28, 1988
MANAN HUBER STYLE INFUSION NEEDLE
K883744 · FMF
Manan Medical Products, Inc.
General Hospital · 27d
Cleared Sep 28, 1988
STORZ MODEL 62 ENT CAMERA SYSTEM
K883760 · FWL
Storz Instrument Co.
General & Plastic Surgery · 22d
Cleared Sep 28, 1988
CCM-1 VIDEO CAMERA SYSTEM
K883943 · FTS
Medical Concepts, Inc.
General & Plastic Surgery · 9d
Cleared Sep 28, 1988
MEC-1 VIDEO COMBO SYSTEM
K883944 · FTS
Medical Concepts, Inc.
General & Plastic Surgery · 9d
Cleared Sep 28, 1988
U. V. SUNLAMP 95UF-11
K883952 · FTC
Light Sources, Inc.
General & Plastic Surgery · 9d
Cleared Sep 27, 1988
ACS CORONARY ANGIOSCOPIC CATHETER
K875108 · LYK
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 288d