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
74809–74832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
K023285 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 23d
Cleared Oct 09, 2002
BOSWORTH CORACO-CLAVICULAR SCREW
K023294 · HWC
Howmedica Osteonics Corp.
Orthopedic · 7d
Cleared Oct 09, 2002
OCO DENTAL IMPLANT (5.0MM DIAMETER)
K023336 · DZE
"O" Co., Inc.
Dental · 2d
Cleared Oct 08, 2002
FOCUS RADIATION TREATMENT PLANNING SYSTEM
K020027 · MUJ
Computerized Medical Systems, Inc.
Radiology · 277d
Cleared Oct 08, 2002
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4
K020507 · GWG
Olympus Winter & Ibe GmbH
Neurology · 235d
Cleared Oct 08, 2002
MODEL 4310 PSARRAY2 EEG ELECTRODE
K020670 · GXY
Physiometrix, Inc.
Neurology · 221d
Cleared Oct 08, 2002
ARTEMIS
K021333 · IYO
Ultralink, LLC
Radiology · 165d
Cleared Oct 08, 2002
SIMPLIFY COMPACT RESUSCITATOR
K021716 · BTM
Polymed (Xiamen) Plastic Industrial...
Anesthesiology · 138d
Cleared Oct 08, 2002
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES...
K021955 · DQA
Datex-Ohmeda, Inc.
Anesthesiology · 116d
Cleared Oct 08, 2002
ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II,...
K022226 · GEX
Altus Medical, Inc.
General & Plastic Surgery · 90d
Cleared Oct 08, 2002
FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES
K022228 · GEX
Iridex Corp
General & Plastic Surgery · 90d
Cleared Oct 08, 2002
KONRAD, MODEL V.2.0
K022307 · MUJ
Mrc Systems GmbH
Radiology · 84d
Cleared Oct 08, 2002
INNOVA AND INNOVA 2000 S
K022322 · OWB
Ge Medical Systems, Inc.
Radiology · 83d
Cleared Oct 08, 2002
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K022441 · JOJ
Advanced Sterilization Products
General Hospital · 75d
Cleared Oct 08, 2002
GETTIG DISPOSABLE SYRINGES
K022495 · FMF
Gettig Pharmaceutical Instrument Co.
General Hospital · 71d
Cleared Oct 08, 2002
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
K022565 · JAA
Stereotaxis, Inc.
Radiology · 67d
Cleared Oct 08, 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022656 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 60d
Cleared Oct 08, 2002
MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
K022781 · LZA
Industrial Clothings, Ltd.
General Hospital · 47d
Cleared Oct 08, 2002
LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST
K022946 · MMI
Princeton BioMeditech Corp.
Chemistry · 34d
Cleared Oct 08, 2002
LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL
K023032 · GFS
Bioresource Technology, Inc.
Chemistry · 27d
Cleared Oct 07, 2002
EXOMIO, MODEL 1.1
K022219 · KPQ
Medcom GmbH
Radiology · 90d
Cleared Oct 07, 2002
TRILUX, Z-TONE, ACRY ROCK
K022299 · ELM
Ruthibras Imp. Exp. Com. DE Materiais...
Dental · 83d
Cleared Oct 07, 2002
CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
K022373 · NJH
Cantor & Nissel , Ltd.
Ophthalmic · 77d
Cleared Oct 07, 2002
PULPDENT CALCIUM HYDROXIDE PREPARATION
K022734 · KIF
Pulpdent Corporation
Dental · 52d