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
80497–80520 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 2001
PALFIQUE ESTELITE LV
K002863 · EBF
Tokuyama America, Inc.
Dental · 113d
Cleared Jan 04, 2001
PHACOGARD
K002932 · HQC
Syntec, Inc.
Ophthalmic · 106d
Cleared Jan 04, 2001
STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES
K003111 · HAW
Stryker Instruments
Neurology · 92d
Cleared Jan 04, 2001
REGAIN DESKTOP
K003127 · HCC
Srs Medical Systems, Inc.
Neurology · 90d
Cleared Jan 04, 2001
VERTEBRAL BODY REPLACEMENT
K003155 · MQP
Osteotech, Inc.
Orthopedic · 86d
Cleared Jan 04, 2001
BIOEMG II AND BIOJVA
K003176 · KZM
Bio-Research Associates, Inc.
Dental · 85d
Cleared Jan 04, 2001
UNICONDYLAR INTERPOSITIONAL SPACER
K003269 · HSH
Sulzer Orthopedics, Inc.
Orthopedic · 78d
Cleared Jan 04, 2001
AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)
K003330 · IYE
Aktina Medical Physics Corp.
Radiology · 72d
Cleared Jan 04, 2001
STICK
K003333 · EBI
Stick Tech , Ltd.
Dental · 71d
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