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
120193–120216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1991
DIRECTIGEN 1-2-3(TM) HCG TEST
K913122 · JHI
Quidel Corp.
Chemistry · 32d
Cleared Aug 16, 1991
JACE MODEL T300 TOE CPM DEVICE
K913227 · BXB
Thera Kinetics, Inc.
Physical Medicine · 25d
Cleared Aug 16, 1991
STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K913236 · DHA
Baxter Healthcare Corp
Toxicology · 25d
Cleared Aug 16, 1991
OPUS(R) PROLACTIN TEST SYSTEM
K913280 · CFT
Pb Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Aug 16, 1991
E-Z CLEAN LAPAROSCOPIC ELECTRODE
K913281 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 23d
Cleared Aug 15, 1991
VER-MED A10014 RESTING EKG ELECTRODE & A10021
K910139 · DRX
Vermont Medical, Inc.
Cardiovascular · 213d
Cleared Aug 15, 1991
NORTEC URETERAL STENT
K910691 · FAD
North American Sterilization &...
Gastroenterology & Urology · 177d
Cleared Aug 15, 1991
TITANIUM CONNECTOR (2 PART)
K910787 · FKO
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 171d
Cleared Aug 15, 1991
HORIZON 2000 EEG MONITORING OPTION
K910945 · GWQ
Mennen Medical, Inc.
Neurology · 162d
Cleared Aug 15, 1991
DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020
K911125 · FAP
Diagnostic Ultrasound Corp.
Gastroenterology & Urology · 155d
Cleared Aug 15, 1991
DIAGNOSTIC ULTRASOUND/URO-GYN UD 511
K911166 · DXT
Diagnostic Ultrasound Corp.
Gastroenterology & Urology · 153d
Cleared Aug 15, 1991
UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION
K911328 · BZO
Intertech Resources, Inc.
Anesthesiology · 142d
Cleared Aug 15, 1991
GROUP AUDITORY TRAINER,FM RECEIVER
K912356 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 79d
Cleared Aug 15, 1991
EXPANDACEL NASAL TAMPONS, MODIFICATION
K912524 · EMX
Surgitrend, Ltd.
Ear, Nose, Throat · 73d
Cleared Aug 14, 1991
PLEASURE PLUS
K902772 · HIS
Medimix Products, Inc.
Obstetrics & Gynecology · 418d
Cleared Aug 14, 1991
OBSTETRICAL VACUUM CUP
K911326 · HDB
Gesco Intl., Inc.
Obstetrics & Gynecology · 141d
Cleared Aug 14, 1991
LAPAROSCOPIC BASKET FLEXIBLE AND RIGID
K911477 · LQC
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 132d
Cleared Aug 14, 1991
COLOR VIDEO CAMERA
K911485 · FET
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 132d
Cleared Aug 14, 1991
LAPAROSCOPIC CHOLANGIOCATH
K911487 · GCA
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 132d
Cleared Aug 14, 1991
ENDOSCOPIC LIGHT SOURCE
K911492 · GCT
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 132d
Cleared Aug 14, 1991
LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER
K911830 · GEX
Laserscope
General & Plastic Surgery · 112d
Cleared Aug 14, 1991
INTRAMEDULLARY HIP SCREW, MODIFICATION
K912162 · KTT
Smith & Nephew Richards, Inc.
Orthopedic · 90d
Cleared Aug 14, 1991
ULCERCARE
K912232 · MCY
Jobst Institute, Inc.
General & Plastic Surgery · 86d
Cleared Aug 14, 1991
DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED
K912550 · KGX
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 65d