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
124249–124272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 1990
WILSON-COOK VARICES TAMPONADE BALLOON CUFF
K902099 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 183d
Cleared Nov 07, 1990
G.E. FLUOROCON 300 IMAGING SYSTEM
K902981 · JAA
Electromek Diagnostic Systems, Inc.
Radiology · 134d
Cleared Nov 07, 1990
BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743)
K903139 · IYE
Siemens Medical Laboratories, Inc.
Radiology · 113d
Cleared Nov 07, 1990
VALVE CONTROLLER FOR MICROMACRO COMPOUNDER
K903159 · LHI
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 112d
Cleared Nov 07, 1990
HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE)
K903613 · FLE
Harvard Apparatus, Inc.
General Hospital · 90d
Cleared Nov 07, 1990
MODEL600 UTERINE ACTIVITY MONITOR
K903623 · HFM
Corometrics Medical Systems, Inc.
Obstetrics & Gynecology · 90d
Cleared Nov 07, 1990
DOPPLER NEEDLE AND FLOW MONITOR
K903625 · DPW
Peripheral Systems Group
Cardiovascular · 89d
Cleared Nov 07, 1990
XPRESS
K903701 · JAK
Toshiba America Medical Systems, In.C
Radiology · 84d
Cleared Nov 07, 1990
URETERAL BALLOON DILATATION CATHETER
K903813 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 79d
Cleared Nov 07, 1990
PSC-1 W/OTHER NUMERICAL
K903821 · JAA
Eigen
Radiology · 79d
Cleared Nov 07, 1990
LASERSAT CO2
K904067 · GEX
Satelec
General & Plastic Surgery · 68d
Cleared Nov 07, 1990
BUCCAL TUBE, BUCCAL ATTACHMENT
K904093 · EJF
Lancer Orthodontics, Inc.
Dental · 62d
Cleared Nov 07, 1990
STERILE SURGEONS GLOVES (ULTRA-TOUCH-LATEX)
K904320 · KGO
R.K.F. Laboratories, Inc.
General Hospital · 48d
Cleared Nov 07, 1990
CIBA CORNING ACS PROLACTIN IMMUNOASSAY
K904714 · CFT
Ciba Corning Diagnostics Corp.
Chemistry · 20d
Cleared Nov 07, 1990
XCALIBER
K904818 · ITI
Everest & Jennings, Inc.
Physical Medicine · 14d
Cleared Nov 07, 1990
HANDI-TRAK WHEELCHAIR SNOW CHAINS
K904913 · KNN
Handi-Trak, Inc.
Physical Medicine · 7d
Cleared Nov 06, 1990
SIEMEN'S SIREMOBILE II C-ARM
K902983 · JAA
Electromek Diagnostic Systems, Inc.
Radiology · 133d
Cleared Nov 06, 1990
MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
K903441 · JHX
Intl. Immunoassay Laboratories, Inc.
Chemistry · 98d
Cleared Nov 06, 1990
CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS
K903560 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 90d
Cleared Nov 06, 1990
ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH.
K903582 · LIT
Catheter Sciences Co.
Cardiovascular · 90d
Cleared Nov 06, 1990
REFLOTRON POTASSIUM TEST TABS
K904033 · CEJ
Boehringer Mannheim Corp.
Chemistry · 67d
Cleared Nov 06, 1990
DUPONT SALICYLATE CALIBRATOR
K904307 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 48d
Cleared Nov 06, 1990
BIOCLONES ELEGANCE LH ELISA KIT
K904387 · CEP
Bioclone Australia Pty , Ltd.
Chemistry · 42d
Cleared Nov 06, 1990
RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235
K904623 · IXQ
Atomic Products Corp.
Radiology · 26d