FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
79825–79848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 2001
IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY
K004013 · JWH
Implex Corp.
Orthopedic · 29d
Cleared Jan 24, 2001
PARSFIX CABLE-SCREW SYSTEM
K003351 · KWP
Spinal Concepts, Inc.
Orthopedic · 90d
Cleared Jan 24, 2001
ZINC PHOSPHATE CEMENT
K003427 · EMA
Rite-Dent Manufacturing Corp.
Dental · 82d
Cleared Jan 24, 2001
STIMATE N601 TENS
K003487 · GZJ
Everyway Medical Instruments Co.,Ltd
Neurology · 72d
Cleared Jan 24, 2001
KENDALL-LTP TURNER SAVE-A-LINE
K003511 · FRP
The Ludlow Company LP
General Hospital · 71d
Cleared Jan 24, 2001
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
K003904 · LYY
Purna Bina Sdn Bhd
General Hospital · 36d
Cleared Jan 24, 2001
DYRACT CEM LCI COMPOMER
K003921 · EMA
Dentsply Intl.
Dental · 35d
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