FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92929–92952 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 1997
ARRHYTHMIA MAPPING SYSTEM (8100/8300)
K965066 · DRF
Cardiac Pathways Corp.
Cardiovascular · 236d
Cleared Aug 11, 1997
PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
K970145 · HIR
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 208d
Cleared Aug 11, 1997
FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM
K971305 · HIH
Gynecare Innovation Center
Obstetrics & Gynecology · 125d
Cleared Aug 11, 1997
OSTEO KIRSCHNER WIRES
K971962 · HTY
Osteonics Corp.
Orthopedic · 75d
Cleared Aug 11, 1997
COHEN DISTRACTOR
K972154 · JEY
Howmedica Leibinger, Inc.
Dental · 63d
Cleared Aug 11, 1997
GUERRERO - BELL DISTRACTOR
K972166 · JEY
Howmedica Leibinger, Inc.
Dental · 63d
Cleared Aug 11, 1997
METAGEN ACTIVELOCK CERCLAGE SYSTEM
K972327 · JDQ
Pacific Materials and Interfaces
Orthopedic · 49d
Cleared Aug 11, 1997
LORENZ PECTUS SUPPORT BAR
K972420 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 45d
Cleared Aug 11, 1997
MVM 3.3 MM MICROENDOSCOPE
K972504 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 39d
Cleared Aug 08, 1997
ELECTROSURGICAL ELECRTRODES
K962271 · HIH
Northgate Technologies, Inc.
Obstetrics & Gynecology · 421d
Cleared Aug 08, 1997
THROMBOLYTIC BRUSH CATHETER
K963925 · MCW
Micro Therapeutics, Inc.
Cardiovascular · 312d
Cleared Aug 08, 1997
ROTAVIRUS EIA
K964424 · LIQ
Trinity Biotech, Inc.
Microbiology · 276d
Cleared Aug 08, 1997
VISION CARDIOPLEGIA DELIVERY SYSTEM
K964571 · DTR
Lifestream Int'L, Inc.
Cardiovascular · 267d
Cleared Aug 08, 1997
SURESCAN
K964831 · GEX
Clinicon Corp.
General & Plastic Surgery · 249d
Cleared Aug 08, 1997
FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL...
K970027 · DXC
Rmds, Inc.
Cardiovascular · 217d
Cleared Aug 08, 1997
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER...
K970695 · MOI
Chiron Diagnostics Corp.
Immunology · 164d
Cleared Aug 08, 1997
GOLD FINGERS
K971183 · LYY
Alliance Rubber Products Sdn. Bhd.
General Hospital · 130d
Cleared Aug 08, 1997
CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER
K971737 · GEX
Cynosure, Inc.
General & Plastic Surgery · 88d
Cleared Aug 08, 1997
PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP
K971812 · CGA
Medisense, Inc.
Chemistry · 84d
Cleared Aug 08, 1997
VANTAGE 2.1 EXSPECT
K971878 · KPS
Adac Laboratories
Radiology · 79d
Cleared Aug 08, 1997
PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM
K972053 · KGI
Lunar Corp.
Radiology · 67d
Cleared Aug 08, 1997
DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA
K972337 · JIR
Diagnostic Chemicals , Ltd.
Chemistry · 46d
Cleared Aug 08, 1997
QUIKPAC II ONE STEP OPIATE TEST
K972405 · DJG
Drial Consultants, Inc.
Toxicology · 43d
Cleared Aug 08, 1997
OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
K972454 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 38d