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

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176,076 results
72577–72600 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 29, 2003
VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC
K030699 · EAG
J. Morita Mfg. Corp.
Radiology · 84d
Cleared May 29, 2003
IPACS PRISM
K030751 · LLZ
Realtimeimage, Inc.
Radiology · 80d
Cleared May 29, 2003
KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW...
K030781 · LLZ
Eastman Kodak Company
Radiology · 79d
Cleared May 29, 2003
LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500
K031011 · GEI
Valleylab, Inc.
General & Plastic Surgery · 59d
Cleared May 29, 2003
PREMIER III PHASED ARRAY CTL SPINE COIL
K031139 · MOS
Usa Instruments, Inc.
Radiology · 49d
Cleared May 29, 2003
ALPHA 5000 WRIST COIL
K031143 · MOS
Usa Instruments, Inc.
Radiology · 49d
Cleared May 29, 2003
SPIRIT III TOTALSENSE CARDIAC COIL
K031172 · MOS
Usa Instruments, Inc.
Radiology · 45d