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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
81097–81120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 2001
BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED)
K003289 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 77d
Cleared Jan 05, 2001
260 CORVUS
K003292 · IYO
Pie Medical
Radiology · 77d
Cleared Jan 05, 2001
2010 PLUS HOLTER FOR WINDOWS
K003763 · MLO
Agilent Technologies
Cardiovascular · 30d
Cleared Jan 05, 2001
MONARCH II IOL DELIVERY SYSTEM
K003768 · MSS
Alcon Research, Ltd.
Ophthalmic · 30d
Cleared Jan 05, 2001
BARD LUMINEXX BILIARY STENT
K003793 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 28d
Cleared Jan 05, 2001
BARD ENDOCINCH SUTURING SYSTEM # 000452
K003956 · ODE
C.R. Bard, Inc.
Gastroenterology & Urology · 15d
Cleared Jan 04, 2001
ELECTROSURGICAL PROBES AND DEVICES-GELTX
K002269 · GEI
Ximed/Prosure/Injectx
General & Plastic Surgery · 162d
Cleared Jan 04, 2001
ASTRA TECH IMPLANTS - DENTAL SYSTEM
K002513 · DZE
Astra Tech, Inc.
Dental · 142d
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