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
80953–80976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2001
SOFRADIM PARIETEX SURGICAL MESHES
K003990 · FTL
Sofradim Production
General & Plastic Surgery · 29d
Cleared Jan 24, 2001
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
K003997 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 24, 2001
STRYKER REMOTE SURGICAL PLANNING SYSTEM
K004027 · HAW
Stryker Instruments
Neurology · 28d
Cleared Jan 24, 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
K010034 · FOZ
Cook, Inc.
General Hospital · 20d
Cleared Jan 24, 2001
NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE
K010038 · FMI
Cambridge Marketing, Inc.
General Hospital · 19d
Cleared Jan 24, 2001
BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR
K991618 · FRC
Propper Mfg. Co., Inc.
General Hospital · 624d
Cleared Jan 24, 2001
THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY,...
K994060 · JEY
Bioplate, Inc.
Dental · 421d
Cleared Jan 23, 2001
HORIZONS ERCP CANNULA
K002235 · FGE
Horizons Intl. Corp.
Gastroenterology & Urology · 183d
Cleared Jan 23, 2001
HORIZONS PAPILLOTOME
K002236 · KNS
Horizons Intl. Corp.
Gastroenterology & Urology · 183d
Cleared Jan 23, 2001
MEDLINE STERILIZATION WRAP
K002968 · FRG
Medline Industries, Inc.
General Hospital · 123d
Cleared Jan 23, 2001
ALGINATE IMPRESSION MATERIAL
K003426 · ELW
Rite-Dent Manufacturing Corp.
Dental · 81d
Cleared Jan 23, 2001
DIFFUSION TENSOR IMAGING OPTION
K003573 · LNH
Ge Medical Systems, Inc.
Radiology · 64d
Cleared Jan 23, 2001
MAGNETOM RHAPSODY SYSTEM
K003628 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 60d
Cleared Jan 23, 2001
VITREA 2 CT PERFUSION OPTION
K003639 · JAK
Vital Images, Inc.
Radiology · 60d
Cleared Jan 23, 2001
CAVEX TEMPORARY CEMENT
K003791 · EMA
Cavex Holland BV
Dental · 46d
Cleared Jan 23, 2001
GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K003872 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 39d
Cleared Jan 23, 2001
MOLINA ORBITAL MALAR DISTRACTOR
K003883 · JEY
KLS-Martin L.P.
Dental · 39d
Cleared Jan 23, 2001
RITA STARBURST XLI ELECTROSURGICAL DEVICE
K010060 · GEI
Rita Medical Systems
General & Plastic Surgery · 15d
Cleared Jan 22, 2001
GLUTARTEST 1 REAGENT STRIP
K002011 · MSY
Integrated Biomedical Technology, Inc.
Gastroenterology & Urology · 203d
Cleared Jan 22, 2001
GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
K002621 · CGA
Apex BioTechnology Corp.
Chemistry · 152d
Cleared Jan 22, 2001
GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM
K002624 · CGA
Apex BioTechnology Corp.
Chemistry · 152d
Cleared Jan 22, 2001
INSTACCULT
K002930 · KHE
Medtek Diagnostics, LLC
Hematology · 124d
Cleared Jan 22, 2001
V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A...
K003042 · LPL
Joe B. Goldberg, O.D.
Ophthalmic · 115d
Cleared Jan 22, 2001
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
K003323 · FTL
Davol, Inc.
General & Plastic Surgery · 90d