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
79993–80016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 2001
ORION PLATINUM
K003367 · HCC
Srs Medical Systems, Inc.
Neurology · 66d
Cleared Jan 04, 2001
ERBE APC HANDLE AND APPLICATORS, MODEL...
K003462 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 58d
Cleared Jan 04, 2001
FRESENIUS OPTIFLUX 200A
K003498 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 52d
Cleared Jan 04, 2001
TEMP-BOND NE 2
K003658 · EMA
Sybron Dental Specialties, Inc.
Dental · 37d
Cleared Jan 04, 2001
GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING...
K003753 · FGE
Uresil Corp.
Gastroenterology & Urology · 30d
Cleared Jan 04, 2001
SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM
K003832 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 24d
Cleared Jan 04, 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K003898 · HRX
Ebi, L.P.
Orthopedic · 17d
Cleared Jan 03, 2001
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE
K003415 · DXQ
Wang & Li, Inc.
Cardiovascular · 62d
Cleared Jan 03, 2001
ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER...
K003729 · DYB
St Jude Medical
Cardiovascular · 30d
Cleared Jan 03, 2001
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH...
K003756 · JEY
Bionx Implants, Inc.
Dental · 28d
Cleared Jan 02, 2001
CASTLE MODEL 233HC STEAM STERILIZER
K003441 · FLE
Getinge/Castle, Inc.
General Hospital · 57d
Cleared Jan 02, 2001
DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES...
K003451 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 56d
Cleared Jan 02, 2001
FLEXICAST
K003509 · EJH
American Dent-All, Inc.
Dental · 49d
Cleared Jan 02, 2001
POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE
K003563 · LZA
Ning BO Yujiang Rubber & Plastic Co.
General Hospital · 43d
Cleared Jan 02, 2001
MODIFICATION TO EBI SPINELINK SYSTEM
K003764 · MNH
Ebi, L.P.
Orthopedic · 27d
Cleared Jan 02, 2001
WATER PURIFICATION SYSTEM
K994292 · FIP
Water & Power Technologies, Inc.
Gastroenterology & Urology · 378d
Cleared Dec 29, 2000
INJECTRITE-C15 AND INJECTRITE-C30
K002127 · FMF
Sterling Medivations, Inc.
General Hospital · 168d
Cleared Dec 29, 2000
AVITA TSO/TS1 INFRARED EAR THERMOMETER
K002182 · FLL
Avita Corporation
General Hospital · 163d
Cleared Dec 29, 2000
BIOMET EXTERNAL WRIST PLATE
K003240 · LXT
Biomet, Inc.
Orthopedic · 73d
Cleared Dec 29, 2000
SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS...
K992424 · LJS
Plastimed Laboratoire Pharmaceutique
General Hospital · 527d
Cleared Dec 28, 2000
EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
K001576 · NBV
Prosurg, Inc.
Obstetrics & Gynecology · 220d
Cleared Dec 28, 2000
INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY...
K003040 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 28, 2000
BRAIN COIL, MODEL 9800GE-64
K003097 · MOS
Midwest Rf, LLC
Radiology · 86d
Cleared Dec 28, 2000
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003212 · JDS
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 76d