Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
50593–50616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 2010
FUORECAM
K093705 · NBL
Therapeutic Technologies, Inc.
Dental · 143d
Cleared Apr 23, 2010
ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276
K093940 · NBW
Taidoc Technology Corporation
Chemistry · 122d
Cleared Apr 23, 2010
LENSX 550 LASER SYSTEM. MODEL 550
K094052 · OOE
Lensx Lasers, Inc.
Ophthalmic · 113d
Cleared Apr 23, 2010
DIALYSATE METER, MODEL D-6
K100237 · FLB
Myron L Company
Gastroenterology & Urology · 87d
Cleared Apr 23, 2010
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE,...
K100283 · BTO
Cook, Inc.
Anesthesiology · 81d
Cleared Apr 23, 2010
12 LEAD GLOVE
K100315 · DRX
I Needmd, Inc.
Cardiovascular · 78d
Cleared Apr 23, 2010
PAP-CAP
K100343 · BZD
Pur-Sleep, Inc.
Anesthesiology · 77d
Cleared Apr 23, 2010
MINXRAY MODEL CMDR-2S
K100449 · IZL
Minxray, Inc.
Radiology · 65d
Cleared Apr 23, 2010
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S
K100528 · ONZ
Breathe Technologies, Inc.
Anesthesiology · 58d
Cleared Apr 23, 2010
ERGO IMAGING SYSTEM
K100838 · IYX
Digirad Corp.
Radiology · 30d
Cleared Apr 23, 2010
INFINITY MCABLE - MAINSTREAM CO2
K100941 · CCK
Draeger Medical AG & Co. KG
Anesthesiology · 18d
Cleared Apr 22, 2010
IVUE, MODEL 100
K091404 · OBO
Optovue, Inc.
Ophthalmic · 345d
Cleared Apr 22, 2010
GRAFTY QUICKSET
K093343 · MQV
Graftys
Orthopedic · 178d
Cleared Apr 22, 2010
TORNIER SURGICAL MESH
K093799 · FTL
Tornier, Inc.
General & Plastic Surgery · 133d
Cleared Apr 22, 2010
PERIOPHIL B-TCP
K093871 · LYC
Cytophil, Inc.
Dental · 126d
Cleared Apr 22, 2010
MODIFICATION TO: HG III ULTRA WIDE SYSTEM
K093889 · DZE
Hiossen, Inc.
Dental · 125d
Cleared Apr 22, 2010
DENTAL HANDPIECE
K093971 · EFB
North West Medical Instrument (Group)...
Dental · 119d
Cleared Apr 22, 2010
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR...
K093974 · NPQ
Osmetech Molecular Diagnostics
Pathology · 120d
Cleared Apr 22, 2010
ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX
K093977 · DQY
Chestnut Medical Technologies, Inc.
Cardiovascular · 119d
Cleared Apr 22, 2010
COMPACT TOUCH
K094038 · IYO
Quantel S.A.
Radiology · 113d
Cleared Apr 22, 2010
MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM
K094045 · LPH
Cardo Medical Corp.
Orthopedic · 112d
Cleared Apr 22, 2010
LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART
K100096 · IYE
Integra Radionics, Inc.
Radiology · 99d
Cleared Apr 22, 2010
VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI...
K100113 · MOS
Sentinelle Medical, Inc.
Radiology · 98d
Cleared Apr 22, 2010
INSTAFLO BOWEL CATHETER SYSTEM KIT
K100273 · KNT
Hollister, Inc.
Gastroenterology & Urology · 83d