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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68689–68712 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 2004
TROPHYPAN AND TROPHYPAN C
K033690 · EHD
Trophy Radiologie
Radiology · 88d
Cleared Feb 20, 2004
MAMMOTOME EX HAND HELD SYSTEM
K033700 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 87d
Cleared Feb 20, 2004
AXSYM CORTISOL ASSAY
K033731 · JFT
Fujirebio Diagnostics,Inc.
Chemistry · 84d
Cleared Feb 20, 2004
SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES
K033805 · LXT
Synthes (Usa)
Orthopedic · 74d
Cleared Feb 20, 2004
ACE PROXIMAL HUMERAL NAIL SYSTEM
K033806 · HSB
Depuy Ace
Orthopedic · 74d
Cleared Feb 20, 2004
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG...
K033809 · KLR
Dade Behring, Inc.
Toxicology · 74d
Cleared Feb 20, 2004
KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY
K033821 · LMC
Eastman Kodak Company
Radiology · 73d
Cleared Feb 20, 2004
ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM
K033878 · HSB
Depuy Ace
Orthopedic · 67d
Cleared Feb 20, 2004
DORC VITRECTOMY LENSES, MODEL 1284 SERIES
K033950 · HJK
Dutch Ophthalmic Research Center...
Ophthalmic · 60d
Cleared Feb 20, 2004
LAD (EPITURE EASYTOUCH), MODEL LAD-08
K033962 · GEX
Norwood Abbey , Ltd.
General & Plastic Surgery · 60d
Cleared Feb 20, 2004
HANSSON PIN SYSTEM
K033968 · HTY
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared Feb 20, 2004
EARLOOP PROCEDURE MASK
K034015 · FXX
Medipack Medical Packaging Mfg. Co.
General Hospital · 58d
Cleared Feb 20, 2004
PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
K034054 · JAI
Med-Tec,Inc.
Radiology · 52d
Cleared Feb 20, 2004
WILSON-COOK USW CAP AND WIRE LOCK
K040137 · OCY
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 20, 2004
OASIS BILIARY STENT INTRODUCTION SYSTEM
K040151 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Feb 20, 2004
OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS
K040199 · JDQ
Osseus, LLC
Orthopedic · 22d
Cleared Feb 20, 2004
TRIGEN INTERTAN
K040212 · JDS
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Feb 20, 2004
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K040221 · CBK
Maquet Critical Care AB
Anesthesiology · 18d
Cleared Feb 20, 2004
GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587
K040251 · IYN
Ge Med. Systems Ultrasound & Prim....
Radiology · 17d
Cleared Feb 20, 2004
SINON POWER WHEELCHAIR, SN-W401
K040319 · ITI
Sinon Corporation
Physical Medicine · 11d
Cleared Feb 19, 2004
MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR
K032551 · DQA
Masimo Corp.
Anesthesiology · 184d
Cleared Feb 19, 2004
IR FOREHEAD THERMOMETER, MODEL HV-T36
K032612 · FLL
Oriental Inspiration, Ltd.
General Hospital · 178d
Cleared Feb 19, 2004
MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5
K033296 · DQA
Masimo Corp.
Anesthesiology · 128d
Cleared Feb 19, 2004
C2 NASAL MASK
K033759 · BZD
Respironics, Inc.
Anesthesiology · 79d