Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
54745–54768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2008
ZUMA, MODEL 55-XXXX/56-XXXX
K082926 · OVD
Seaspine, Inc.
Orthopedic · 82d
Cleared Dec 22, 2008
EZLASE
K082938 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 81d
Cleared Dec 22, 2008
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND...
K082953 · KXT
Biokit, S.A.
Toxicology · 80d
Cleared Dec 22, 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS...
K083173 · JLW
Ortho-Clinical Diagnostics
Chemistry · 56d
Cleared Dec 22, 2008
NOVEON MODEL LS1100-03
K083476 · GEX
Nomir Medical Technologies, Inc.
General & Plastic Surgery · 28d
Cleared Dec 22, 2008
ABT GLUCOSE CONTROL SOLUTION
K083549 · JJX
American Biological Technologies, Inc.
Chemistry · 21d
Cleared Dec 19, 2008
CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS
K081083 · OAV
Thermo Fisher Scientific
Toxicology · 247d
Cleared Dec 19, 2008
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI...
K081207 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 234d
Cleared Dec 19, 2008
E.COLI/P. AERUGINOSA PNA FISH
K081309 · JSS
Advandx, Inc.
Microbiology · 224d
Cleared Dec 19, 2008
PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)
K081608 · HRS
Toby Orthopaedics, LLC
Orthopedic · 193d
Cleared Dec 19, 2008
ADIN DENTAL IMPLANTS SYSTEM
K081751 · DZE
Adin Dental Implants System, Ltd.
Dental · 183d
Cleared Dec 19, 2008
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
K081827 · CFN
The Binding Site, Ltd.
Immunology · 175d
Cleared Dec 19, 2008
IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)
K081855 · DJZ
Canada, Inc.
Toxicology · 172d
Cleared Dec 19, 2008
BD GENEOHM CDIFF ASSAY
K081920 · LLH
Bd Diagnostics (Geneohm Sciences, Inc.)
Microbiology · 169d
Cleared Dec 19, 2008
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
K081930 · GKZ
Beckman Coulter, Inc.
Hematology · 165d
Cleared Dec 19, 2008
KEY RING ALCOHOL BREATHALYZER
K082086 · DJZ
The Ashley Collection, Inc.
Toxicology · 149d
Cleared Dec 19, 2008
ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00
K082114 · KNS
Apollo Endosurgery, Inc.
Gastroenterology & Urology · 144d
Cleared Dec 19, 2008
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS,...
K082503 · DFH
Siemens Healthcare Diagnostics
Immunology · 112d
Cleared Dec 19, 2008
VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES
K082630 · DXQ
Zefon Intl.
Cardiovascular · 100d
Cleared Dec 19, 2008
ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS
K082639 · DZE
Zimmer Dental, Inc.
Dental · 100d
Cleared Dec 19, 2008
3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM...
K082643 · GEI
Depuy Mitek, A Johnson & Johnson Company
General & Plastic Surgery · 99d
Cleared Dec 19, 2008
RIMCLOSE BONE ANCHOR
K082729 · MBI
Anulex Technologies, Inc.
Orthopedic · 92d
Cleared Dec 19, 2008
PRISMAFLO II
K082758 · KOC
Stihler Electronic GmbH
Gastroenterology & Urology · 91d
Cleared Dec 19, 2008
STRYKER LED LIGHTSOURCE
K082813 · FCW
Stryker Corp.
Gastroenterology & Urology · 86d