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
79969–79992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 2001
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION
K003827 · FMI
Bio-Plexus, Inc.
General Hospital · 28d
Cleared Jan 08, 2001
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
K003925 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 19d
Cleared Jan 08, 2001
INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND...
K990800 · DSY
Intervascular, Inc.
Cardiovascular · 670d
Cleared Jan 06, 2001
OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT...
K003136 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 92d
Cleared Jan 05, 2001
KELO-COTE TOPICAL GEL
K002488 · MDA
Advanced Bio-Technologies, Inc.
General & Plastic Surgery · 144d
Cleared Jan 05, 2001
LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML
K003031 · LPN
Alpha Vista, Inc.
Ophthalmic · 99d
Cleared Jan 05, 2001
MIZAR, BASIS BE, SANDMAN DIGITAL
K003154 · GWL
Eb Neuro S.P.A.
Neurology · 87d
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