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
99505–99528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 1995
ADULT VENTILATOR
K943106 · CBK
Infrasonics Corp.
Anesthesiology · 547d
Cleared Dec 28, 1995
BETA FEMORAL HIP STEM
K945774 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 398d
Cleared Dec 28, 1995
POP-N-LOK SYRINGE
K946219 · MEG
Retractable Technologies, Inc.
General Hospital · 372d
Cleared Dec 28, 1995
J SINGLE USE HEAD AND JD REUSABLE HANDLE
K950555 · EGS
Micro-Mega Societe Anonyme
Dental · 324d
Cleared Dec 28, 1995
DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR
K952494 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 212d
Cleared Dec 28, 1995
TOWNLEY ALL POLY ACETABULAR CUP
K952731 · JDI
Biologically Oriented Prostheses
Orthopedic · 196d
Cleared Dec 28, 1995
FOAM INSTRUMENT GUARD
K952787 · KCT
Oxboro Medical Intl., Inc.
General Hospital · 192d
Cleared Dec 28, 1995
SURGEONS GLOVE POWDER FREE
K953358 · KGO
American Pro Latex, Inc.
General Hospital · 164d
Cleared Dec 28, 1995
ATLANTIS
K953936 · EAP
Trophy Radiologie
Radiology · 129d
Cleared Dec 28, 1995
WESTMED CONDESATE COLLECTION TRAP
K954271 · CAW
Westmed Intl.
Anesthesiology · 107d
Cleared Dec 28, 1995
ULTRAFIT LINERS
K954314 · LYU
Stahmer Weston Scientific
General Hospital · 104d
Cleared Dec 28, 1995
BLOOD GAS MIXTURE
K954546 · JIS
Liquid Technology Corp.
Chemistry · 90d
Cleared Dec 28, 1995
CORDIS BRITE TIP SHEATH INTRODUCER
K954595 · DYB
Cordis Corp.
Cardiovascular · 86d
Cleared Dec 28, 1995
AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER
K954637 · EBI
American Dental Products, Inc.
Dental · 83d
Cleared Dec 28, 1995
ENDO-LEADER
K954641 · OCW
Microsurge, Inc.
General & Plastic Surgery · 79d
Cleared Dec 28, 1995
POWDER FREE PLUS PATIENT EXAMINATION GLOVE
K954855 · LYY
Tillotson Healthcare Corp.
General Hospital · 66d
Cleared Dec 28, 1995
FLEXIBLE INTRAMEDULLARY REAMER
K954915 · HTO
Zimmer, Inc.
Orthopedic · 63d
Cleared Dec 28, 1995
AQUACENTER 2000 SYSTEM
K954964 · HRX
Aquarius Medical Corp.
Orthopedic · 59d
Cleared Dec 28, 1995
D-SENSE
K955279 · KLE
Centrix, Inc.
Dental · 42d
Cleared Dec 28, 1995
SCAN WHITE 12 ML
K955406 · ELW
Vident
Dental · 31d
Cleared Dec 28, 1995
DEGUPRINT
K955465 · ELW
Degussa Corp.
Dental · 28d
Cleared Dec 28, 1995
MIDAS GOLD ELECTROFORMING SYSTEM
K955509 · EJT
Austenal, Inc.
Dental · 24d
Cleared Dec 28, 1995
RANIR HI-TECHNOLOGY DENTAL FLOSS
K955530 · EFW
Ranir/Dcp Corp.
Dental · 24d
Cleared Dec 27, 1995
ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES
K951910 · GEX
Xintec Corporation
General & Plastic Surgery · 247d