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
80329–80352 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 2001
TWILITE, TWILITE WHITE
K003385 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 86d
Cleared Jan 25, 2001
CARDIO MONITOR CENTER VISION
K003392 · DPS
Shl Telemedicine International , Ltd.
Cardiovascular · 86d
Cleared Jan 25, 2001
PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM
K003460 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 79d
Cleared Jan 25, 2001
DENLASER, MODEL 800
K003541 · GEX
CAO Group, Inc.
General & Plastic Surgery · 70d
Cleared Jan 25, 2001
Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
K003576 · DSI
Quinton, Inc.
Cardiovascular · 66d
Cleared Jan 25, 2001
HARDYDISK SULFISOXAZOLE
K003690 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared Jan 25, 2001
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG,...
K003696 · DHA
Dade Behring, Inc.
Chemistry · 56d
Cleared Jan 25, 2001
ELECSYS HCG STAT CLASET II
K003941 · JIS
Roche Diagnostics Corp.
Chemistry · 35d
Cleared Jan 25, 2001
DR180+OXY
K004007 · DSH
North East Monitoring, Inc.
Cardiovascular · 30d
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