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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
39001–39024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 2013
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
K131229 · OTN
American Medical Systems
Gastroenterology & Urology · 219d
Cleared Dec 05, 2013
MCKESSON CARDIOLOGY HEMO
K131497 · MWI
Mckesson Israel , Ltd.
Cardiovascular · 195d
Cleared Dec 05, 2013
UD IMPLANT SYSTEM
K131682 · DZE
Medimecca Co., Ltd.
Dental · 178d
Cleared Dec 05, 2013
TFCC FAST-FIX KIT
K132079 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 153d
Cleared Dec 05, 2013
AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
K132082 · MST
Aesku Diagnostics
Immunology · 153d
Cleared Dec 05, 2013
SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER
K132153 · FOZ
Nipro Medical Corporation
General Hospital · 146d
Cleared Dec 05, 2013
AEQUALIS REVERSED SHOULDER PROSTHESIS
K132285 · PHX
Tornier S.A.S.
Orthopedic · 135d
Cleared Dec 05, 2013
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K132640 · HSX
Conformis, Inc.
Orthopedic · 104d
Cleared Dec 05, 2013
ZIEHM VISION RFD
K132904 · JAA
Ziehm Imaging GmbH
Radiology · 80d
Cleared Dec 05, 2013
GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE...
K132966 · NBW
Infopia Co, Ltd.
Chemistry · 76d
Cleared Dec 05, 2013
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
K132994 · KWQ
Corelink, LLC
Orthopedic · 72d
Cleared Dec 05, 2013
STARCERAM
K133213 · EIH
H.C. Starck Ceramics GmbH
Dental · 48d
Cleared Dec 05, 2013
AEQUALIS HUMERAL NAIL
K133376 · HSB
Tornier, Inc.
Orthopedic · 31d
Cleared Dec 05, 2013
ALERE BINAXNOW INFLUENZA A & B CARD
K133411 · GNX
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 28d
Cleared Dec 05, 2013
SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP...
K133425 · FTD
Engineered Medical Solutions Co., LLC
General & Plastic Surgery · 27d
Cleared Dec 04, 2013
NIPRO PUREFLUX-L HEMODIALYZER
K122952 · FJI
Nipro Medical Corporation
Gastroenterology & Urology · 435d
Cleared Dec 04, 2013
SELF-RETAINING BICANALICULUS INTUBATON SET II
K130375 · OKS
Fci Sas (France Chirurgie...
Ophthalmic · 293d
Cleared Dec 04, 2013
MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E...
K131957 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 160d
Cleared Dec 04, 2013
HEINE BETA 200(R) OPHTHALMOSCOPE
K131961 · HLJ
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 160d
Cleared Dec 04, 2013
BM3/BM3 PLUS
K132033 · MWI
Noblitt & Rueland
Cardiovascular · 156d
Cleared Dec 04, 2013
S HEALTH
K132148 · DRG
Samsung Electronics Co., Ltd.
Cardiovascular · 146d
Cleared Dec 04, 2013
MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
K132232 · OCW
Minilap Technologies
Gastroenterology & Urology · 139d
Cleared Dec 04, 2013
MARS HOLTER ANALYSIS WORKSTATION
K132437 · DQK
Ge Medical Systems Information...
Cardiovascular · 121d
Cleared Dec 04, 2013
MYLABSEVEN 6400, MYLABALPHA 7400
K132466 · IYN
Esaote, S.P.A.
Radiology · 119d