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
61801–61824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 2006
BOOMERANG WIRE
K061075 · DXC
Cardiva Medical, Inc.
Cardiovascular · 137d
Cleared Sep 01, 2006
EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES
K061134 · HRX
Efs Eberle Feinwerktechnische Systeme
Orthopedic · 130d
Cleared Sep 01, 2006
WELLFLEX BILIARY RX STENT SYSTEM
K061231 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 122d
Cleared Sep 01, 2006
PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD
K061564 · LZO
Portland Orthopaedics Pty. , Ltd.
Orthopedic · 88d
Cleared Sep 01, 2006
POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH
K061649 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 80d
Cleared Sep 01, 2006
SM IMPLANT SYSTEMS
K061797 · DZE
Dio Department Dsi, Inc.
Dental · 67d
Cleared Sep 01, 2006
AGFA MODEL CR30-X
K062223 · MQB
Agfa Corporation
Radiology · 30d
Cleared Sep 01, 2006
MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML)
K062290 · LRG
Dade Behring, Inc.
Microbiology · 25d
Cleared Sep 01, 2006
XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS
K062307 · GAT
Anulex Technologies, Inc.
General & Plastic Surgery · 24d
Cleared Sep 01, 2006
MODIFICATION TO NUVASIVE SPHERX II SYSTEM
K062317 · MNH
Nuvasive, Inc.
Orthopedic · 23d
Cleared Sep 01, 2006
AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE
K062326 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 23d
Cleared Sep 01, 2006
GE VANTAGE PET NEURO SOFTWARE
K062393 · KPS
Ge Healthcare
Radiology · 16d
Cleared Sep 01, 2006
HEMOSIL PROTEIN C
K062430 · GGP
Instrumentation Laboratory CO
Hematology · 11d
Cleared Sep 01, 2006
HEMOSIL LIQUID ANTITHROMBIN
K062431 · JBQ
Instrumentation Laboratory CO
Hematology · 11d
Cleared Aug 31, 2006
CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM
K052687 · JWH
Conformis, Inc.
Orthopedic · 337d
Cleared Aug 31, 2006
BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5
K053556 · MNW
Jawon Medical Co., Ltd.
Gastroenterology & Urology · 254d
Cleared Aug 31, 2006
RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY...
K060397 · GXI
PAJUNK GmbH Medizintechnologie
Neurology · 197d
Cleared Aug 31, 2006
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K061045 · NLH
Alliance Medical Corp.
Cardiovascular · 139d
Cleared Aug 31, 2006
AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
K061248 · HAW
Medtronic Navigation, Inc.
Neurology · 120d
Cleared Aug 31, 2006
EVIS EXERA 180 SYSTEM
K061313 · EOQ
Olympus Medical Systems Corporation
Ear, Nose, Throat · 113d
Cleared Aug 31, 2006
ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM
K061555 · GCJ
Anchor Products Co.
General & Plastic Surgery · 87d
Cleared Aug 31, 2006
PRIMUS GPS BILIARY STENT SYSTEM
K061566 · FGE
Ev3, Inc.
Gastroenterology & Urology · 86d
Cleared Aug 31, 2006
VITALSENSE XHR
K061870 · GWK
Respironics, Inc.
Neurology · 59d
Cleared Aug 31, 2006
ELECSYS IGE II IMMUNOASSAY
K061970 · JHR
Roche Diagnostics
Immunology · 50d