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
83665–83688 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 2000
TOKUYAMA ONE-UP-BOND F
K993917 · KLE
Tokuyama America, Inc.
Dental · 77d
Cleared Feb 02, 2000
ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT
K994261 · EMA
Ultradent Products, Inc.
Dental · 47d
Cleared Feb 01, 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS...
K000044 · GEI
Arthrocare Corp.
General & Plastic Surgery · 25d
Cleared Feb 01, 2000
IONTOPATCH
K992708 · EGJ
Birch Point Medical, Inc.
Physical Medicine · 174d
Cleared Feb 01, 2000
AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
K993085 · MID
Cogent Diagnotics , Ltd.
Immunology · 139d
Cleared Feb 01, 2000
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION...
K993547 · CFN
Beckman Coulter, Inc.
Immunology · 105d
Cleared Feb 01, 2000
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION...
K993549 · CFN
Beckman Coulter, Inc.
Immunology · 105d
Cleared Feb 01, 2000
GTI-FVIII INHIBITOR ASSAY
K993553 · GGP
Genetic Testing Institute
Hematology · 104d
Cleared Feb 01, 2000
HSV-2 ELISA IGG, MODEL EL0920G
K993724 · MYF
Mrl Diagnostics
Microbiology · 90d
Cleared Feb 01, 2000
CERALAS D10 810NM DIODE LASER
K993828 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 81d
Cleared Feb 01, 2000
JE 2000
K993878 · IKN
Jack'S Electrodes
Neurology · 78d
Cleared Feb 01, 2000
INTRASTENT DOUBLESTRUT LD
K993904 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 76d
Cleared Feb 01, 2000
TAC' PIN
K993910 · JDW
New Deal, S.A.
Orthopedic · 76d
Cleared Feb 01, 2000
CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50
K993911 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 77d
Cleared Feb 01, 2000
SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
K993980 · DML
Syva Co.
Toxicology · 69d
Cleared Feb 01, 2000
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
K993981 · JXN
Syva Co.
Toxicology · 69d
Cleared Feb 01, 2000
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
K994035 · JIR
Diagnostic Chemicals , Ltd.
Chemistry · 64d
Cleared Feb 01, 2000
HARDYDISK CEFACLOR 30MCG
K994046 · JTN
Hardy Diagnostics
Microbiology · 64d
Cleared Feb 01, 2000
3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM
K994148 · JQC
Implant Innovations, Inc.
Immunology · 55d
Cleared Feb 01, 2000
ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
K994346 · CHL
Sendx Medical, Inc.
Chemistry · 40d
Cleared Jan 31, 2000
SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1
K000048 · FMF
Biosurgical Corp.
General Hospital · 24d
Cleared Jan 31, 2000
ULTRASHAPER KERATOME
K990227 · HNO
Lasersight Technologies, Inc.
Ophthalmic · 371d
Cleared Jan 31, 2000
KERLIX MD ANTIMICROBIAL GAUZE DRESSING
K990530 · NAD
The Kendall Company, L.P.
General & Plastic Surgery · 346d
Cleared Jan 31, 2000
ROTARY MASTER
K992648 · EBW
J. Morita USA, Inc.
Dental · 178d