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
85633–85656 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 1999
INSULSCAN INSULATION TESTING SYSTEM
K991424 · HFG
Medicor Corp.
Obstetrics & Gynecology · 90d
Cleared Jul 22, 1999
SNORE-AID PLUS
K991449 · LRK
Dental Imagineers, LLC
Dental · 87d
Cleared Jul 22, 1999
REDI-TEST METHAMPHETAMINE
K991504 · LAF
Redwood Biotech, Inc.
Toxicology · 84d
Cleared Jul 22, 1999
COBAS INTEGRA AMIKACIN MAB
K991597 · LGJ
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Jul 22, 1999
COBAS INTEGRA ACETAMINOPHEN
K991598 · LDP
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Jul 22, 1999
TRANSFX MULTI PIN CLAMP
K991723 · LXT
Immedica, Inc.
Orthopedic · 63d
Cleared Jul 22, 1999
BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
K991741 · JHI
Biocheck, Inc.
Chemistry · 62d
Cleared Jul 22, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K991817 · CIJ
Bayer Corp.
Chemistry · 56d
Cleared Jul 22, 1999
QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM
K992207 · DIO
Syntron Bioresearch, Inc.
Toxicology · 22d
Cleared Jul 21, 1999
ANSELL CONDOMS
K984392 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 225d
Cleared Jul 21, 1999
MEDRAD VISTRON CT INJECTOR SYSTEM
K991557 · DXT
Medrad, Inc.
Cardiovascular · 78d
Cleared Jul 21, 1999
EMS SWISS ORTHOCLAST
K991588 · HSZ
(Ems Sa) Electro Medical Systems
Orthopedic · 75d
Cleared Jul 21, 1999
PRO-GLASS
K991844 · EIH
Cad Cam Ventures
Dental · 54d
Cleared Jul 21, 1999
SCIMED ANGIOGRAPHIC CATHETERS
K992142 · DQO
Scimed
Cardiovascular · 27d
Cleared Jul 21, 1999
FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800
K992328 · DXN
Meditec Co., Ltd.
Cardiovascular · 9d
Cleared Jul 20, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
K984180 · LFX
Zeus Scientific, Inc.
Microbiology · 239d
Cleared Jul 20, 1999
SYNOCTA PROSTHETICS
K990342 · DZE
Straumann USA
Dental · 166d
Cleared Jul 20, 1999
CHROMOPHARE D 530 LDR SURGICAL LIGHT
K990656 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 141d
Cleared Jul 20, 1999
OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM
K990712 · MJT
Howmedica Osteonics Corp.
Orthopedic · 138d
Cleared Jul 20, 1999
ENDOSCOPIC CAMERA
K991416 · GCJ
Genzyme Surgical Product (Genzyme...
General & Plastic Surgery · 88d
Cleared Jul 20, 1999
DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50
K991464 · GEX
Fisma, Inc.
General & Plastic Surgery · 84d
Cleared Jul 20, 1999
AWARE PAD
K991469 · IYO
Aac Consulting Group, Inc.
Radiology · 83d
Cleared Jul 20, 1999
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
K991525 · DXQ
Deroyal Industries, Inc.
Cardiovascular · 78d
Cleared Jul 20, 1999
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
K991608 · KMF
Dermaphylyx, Inc.
General & Plastic Surgery · 71d