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
71449–71472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2003
FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON...
K030593 · LPL
X-Cel Contacts, A Walman Co.
Ophthalmic · 94d
Cleared May 30, 2003
STRYKER PAINPUMP2
K030661 · MEA
Stryker Instruments
General Hospital · 88d
Cleared May 30, 2003
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
K030726 · DTN
Gish Biomedical, Inc.
Cardiovascular · 84d
Cleared May 30, 2003
PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES...
K030813 · EZL
Primary Care Solutions, Inc.
Gastroenterology & Urology · 77d
Cleared May 30, 2003
MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)
K030839 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 74d
Cleared May 30, 2003
REBILDA DC
K030914 · EBF
Voco GmbH
Dental · 67d
Cleared May 30, 2003
GRANDIO
K030915 · EBF
Voco GmbH
Dental · 67d
Cleared May 30, 2003
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
K030972 · KWL
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 63d
Cleared May 30, 2003
CAREO RETRACTABLE SAFETY SYRINGE
K030976 · MEG
Life-Shield Products, Inc.
General Hospital · 63d
Cleared May 30, 2003
MSI SA ELECTRODES
K030996 · GEI
Medsphere International, Inc.
General & Plastic Surgery · 60d
Cleared May 30, 2003
SYS*STIM 208 AND 208A
K031017 · IPF
Mettler Electronics Corp.
Physical Medicine · 60d
Cleared May 30, 2003
SURSHIELD SAFETY WINGED INFUSION SET
K031266 · FPA
Terumo Corp.
General Hospital · 39d
Cleared May 30, 2003
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
K031279 · FPA
Terumo Medical Products Hangzhou Co.,...
General Hospital · 38d
Cleared May 30, 2003
LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND...
K031362 · KKX
Lac Mac, Ltd.
General Hospital · 99d
Cleared May 30, 2003
MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3
K031364 · JJY
Medical Analysis Systems, Inc.
Chemistry · 30d
Cleared May 30, 2003
FRESENIUS ULTRAFLUX HEMODIALYZER
K031378 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 29d
Cleared May 30, 2003
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1
K031403 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 25d
Cleared May 30, 2003
EXOJET TISSUE MANAGEMENT SYSTEM
K031406 · HRX
Mitek Worldwide
Orthopedic · 25d
Cleared May 30, 2003
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
K031508 · JDQ
Synthes (Usa)
Orthopedic · 16d
Cleared May 30, 2003
STARCAST DENTAL ALLOYS
K031543 · EJT
Star Refining Precious Metals South...
Dental · 14d
Cleared May 30, 2003
MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
K031552 · IYN
Medison America, Inc.
Radiology · 11d
Cleared May 29, 2003
CARECOMPANION PATIENT STATION & NURSE STATION
K022274 · DRG
Neptec Design Group, Ltd.
Cardiovascular · 318d
Cleared May 29, 2003
PACEART SYSTEM
K024278 · DPS
Medtronic Vascular
Cardiovascular · 157d
Cleared May 29, 2003
TOKUYAMA SOFRELINER TOUGH
K030663 · EBI
Tokuyama Dental Corporation
Dental · 87d