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
63889–63912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 2006
ALIGNRT
K052682 · IYE
Vision RT Limited
Radiology · 100d
Cleared Jan 06, 2006
RAPHAEL COLOR
K052863 · CBK
Hamilton Medical AG
Anesthesiology · 87d
Cleared Jan 06, 2006
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED...
K052964 · DSY
Boston Scientific Corp
Cardiovascular · 77d
Cleared Jan 06, 2006
NDR+/DIVA-D
K053029 · MQB
Nical Spa
Radiology · 71d
Cleared Jan 06, 2006
CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2
K053062 · KPS
Cardiarc , Ltd.
Radiology · 67d
Cleared Jan 06, 2006
MAYFIELD SCANMATE MOBILE CT SYSTEM
K053210 · JAK
Schaerer Mayfield USA, Inc.
Radiology · 51d
Cleared Jan 06, 2006
VERAVIEW IC 5, MODEL XDP1
K053220 · MUH
J. Morita USA, Inc.
Radiology · 50d
Cleared Jan 06, 2006
PITT-EASY DENTAL IMPLANT SYSTEM
K053242 · DZE
Innova Life Sciences Corp.
Dental · 49d
Cleared Jan 06, 2006
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
K053322 · FAS
Roei Medical Technologies, Ltd.
Gastroenterology & Urology · 37d
Cleared Jan 06, 2006
ESTECH COBRA ELECTROSURGICAL UNIT & CABLE
K053326 · GEI
Endoscopic Technologies, Inc.
General & Plastic Surgery · 36d
Cleared Jan 06, 2006
GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
K053410 · FEG
Kendall
Gastroenterology & Urology · 30d
Cleared Jan 06, 2006
EKOS MICRO-INFUSION SYSTEM
K053437 · NUI
Ekos Corp.
Neurology · 28d
Cleared Jan 06, 2006
SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT
K053445 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 25d
Cleared Jan 06, 2006
CD HORIZON SPINAL SYSTEM
K053474 · NKB
Medtronic Sofamor Danek
Orthopedic · 24d
Cleared Jan 05, 2006
KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
K051847 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 182d
Cleared Jan 05, 2006
CD HORIZON SPINAL SYSTEM
K053101 · NKB
Medtronic Sofamor Danek
Orthopedic · 62d
Cleared Jan 05, 2006
5TH METATARSAL FRACTURE SCREW
K053136 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 57d
Cleared Jan 05, 2006
TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM
K053209 · DXN
Suntech Medical, Inc.
Cardiovascular · 50d
Cleared Jan 05, 2006
CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES
K053272 · KGO
Cardinalhealth
General Hospital · 43d
Cleared Jan 05, 2006
MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM
K053285 · IPF
Durtech System Corp.
Physical Medicine · 41d
Cleared Jan 05, 2006
REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
K053299 · HRY
Biomet Manufacturing, Inc.
Orthopedic · 41d
Cleared Jan 05, 2006
CHROMOLITE SYSTEM
K053324 · GEX
Chromogenex Plc
General & Plastic Surgery · 35d
Cleared Jan 05, 2006
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K053483 · MNI
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Jan 04, 2006
QUANTA SYSTEM ETRNA GIOVINEZZA
K051113 · GEX
Quanta System Spa
General & Plastic Surgery · 247d