FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
101401–101424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1995
ADI CATHETER WITH VALVE
K952924 · GBM
Asia Dynamics, Inc.
Gastroenterology & Urology · 53d
Cleared Aug 18, 1995
LINDNER/GOLOMB SP INTRODUCING SOUND
K953024 · KOB
Cook Urological, Inc.
Gastroenterology & Urology · 50d
Cleared Aug 18, 1995
HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE
K953232 · KNT
Hollister, Inc.
Gastroenterology & Urology · 39d
Cleared Aug 18, 1995
PERMADYNE GARANT 2:1
K953374 · ELW
Espe GmbH & Co. Kg.
Dental · 31d
Cleared Aug 18, 1995
RIZA-RIBE NEEDLE
K953441 · FBK
R-Med, Inc.
Gastroenterology & Urology · 32d
Cleared Aug 17, 1995
CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER
K945693 · LIT
Cardiovascular Dynamics, Inc.
Cardiovascular · 269d
Cleared Aug 17, 1995
DIGITAL AVERAGING TONOMETER
K945972 · HKX
Opti-Med Electronics
Ophthalmic · 252d
Cleared Aug 17, 1995
HOLTER PACERCORDER(R)
K950020 · DSH
Del Mar Avionics
Cardiovascular · 225d
Cleared Aug 17, 1995
BRAUN SELECTIVE ANGIOGRAPHIC CATHETER
K950882 · DQO
B.Braun Medical, Inc.
Cardiovascular · 170d
Cleared Aug 17, 1995
ONE STEP URINE DRUG OF ABUSE COCAINE TEST
K951892 · DIO
Tcpi, Inc.
Toxicology · 115d
Cleared Aug 17, 1995
ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE)
K952096 · DJG
Tcpi, Inc.
Toxicology · 105d
Cleared Aug 17, 1995
CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS
K952180 · CHI
Beckman Instruments, Inc.
Chemistry · 100d
Cleared Aug 17, 1995
NELLCOR SYMPHONY N-3000 PULSE OXIMETER
K952316 · DQA
Nellcor, Inc.
Anesthesiology · 92d
Cleared Aug 17, 1995
MEDI-TECH PLATFORM GUIDE CATHETER
K952345 · DQY
Medi-Tech, Inc.
Cardiovascular · 90d
Cleared Aug 17, 1995
TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM
K952741 · CDT
Medical Diagnostic Technologies, Inc.
Chemistry · 62d
Cleared Aug 16, 1995
HERCULES RADIATION THERAPY COUCH
K950061 · IYE
Precision Therapy Intl., Inc.
Radiology · 222d
Cleared Aug 16, 1995
CENTRALITE(R)-DLL SERIES
K950112 · IWE
Diacor, Inc.
Radiology · 217d
Cleared Aug 16, 1995
CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER
K950684 · GEX
Cynosure, Inc.
General & Plastic Surgery · 183d
Cleared Aug 16, 1995
ULTRATHIN URETEROSCOPES
K951855 · FGB
Olympus America, Inc.
Gastroenterology & Urology · 117d
Cleared Aug 16, 1995
VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION
K952313 · LLZ
Varian Assoc., Inc.
Radiology · 91d
Cleared Aug 16, 1995
AOI LC-40 PHACOEMULSIFIER
K952331 · HQC
American Optisurgical, Inc.
Ophthalmic · 90d
Cleared Aug 16, 1995
SALINE DRESSING
K952948 · FRO
Busse Hospital Disposables, Inc.
General & Plastic Surgery · 51d
Cleared Aug 16, 1995
NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER
K953481 · GCJ
American Hydro-Surgical Instruments,...
General & Plastic Surgery · 23d
Cleared Aug 16, 1995
BIPOLAR COAGULATING FORCEPS
K953509 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 21d