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
92425–92448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 08, 1997
QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)
K972618 · DMN
Phamatech
Toxicology · 28d
Cleared Aug 08, 1997
BACTEC MYCO/F-SPUTA CULTURE VIALS
K972758 · MDB
Becton Dickinson Microbiology Systems
Microbiology · 53d
Cleared Aug 07, 1997
QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT
K964616 · LPH
Whiteside Biomechanics, Inc.
Orthopedic · 287d
Cleared Aug 07, 1997
RANSFORD CERVICAL FIXATION SYSTEM
K965221 · KWP
Surgicraft , Ltd.
Orthopedic · 219d
Cleared Aug 07, 1997
JMS AV FISTULA NEEDLE
K970962 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 143d
Cleared Aug 07, 1997
ACCURUN 120 HAV IGG POSITIVE CONTROL
K971406 · JJY
Boston Biomedica, Inc.
Microbiology · 113d
Cleared Aug 07, 1997
SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS
K971715 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Aug 07, 1997
ENDOPATH RESPOSABLE TROCAR SYSTEM
K971738 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 87d
Cleared Aug 07, 1997
IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL
K971807 · ESD
Hear-Right, Inc.
Ear, Nose, Throat · 84d