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
63481–63504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2006
U2 TOTAL KNEE SYSTEM
K051640 · JWH
United Orthopedic Corp.
Orthopedic · 254d
Cleared Mar 01, 2006
CLINTON ELECTRONICS SERIES II DIGITAL GRAYSCALE MONITORS, MODELS DL2000,...
K053039 · LLZ
Clinton Electronics Corp.
Radiology · 125d
Cleared Mar 01, 2006
VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING...
K053087 · GEX
Biotex, Inc.
General & Plastic Surgery · 119d
Cleared Mar 01, 2006
MYSET PREGNANCY TEST
K053138 · LCX
Ani Biotech OY
Chemistry · 112d
Cleared Mar 01, 2006
EASYMATE BLOOD GLUCOSE MONITORING SYSTEM
K053312 · NBW
Bioptik Technology, Inc.
Chemistry · 93d
Cleared Mar 01, 2006
COLORBITE
K053619 · ELW
Zhermack S.P.A.
Dental · 64d
Cleared Mar 01, 2006
INTEGRA
K053640 · LNS
Direx Systems Corp.
Gastroenterology & Urology · 61d
Cleared Mar 01, 2006
STRYKER INJECTABLE CEMENT
K060061 · MQV
Stryker Corp.
Orthopedic · 51d
Cleared Mar 01, 2006
MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA)...
K060420 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 12d
Cleared Feb 28, 2006
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
K050828 · MOL
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 333d
Cleared Feb 28, 2006
KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
K052450 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 174d
Cleared Feb 28, 2006
CURAY CUSTOM SEED ARRAY
K053595 · KXK
Biolucent, Inc.
Radiology · 67d
Cleared Feb 28, 2006
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC...
K053609 · DQE
Edwards Lifesciences, LLC
Cardiovascular · 63d
Cleared Feb 28, 2006
PROFILE MULTI-PLATFORM SYSTEM
K060033 · GEX
Sciton, Inc
General & Plastic Surgery · 54d
Cleared Feb 28, 2006
NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
K060034 · OCY
Nipro Medical Corporation
Gastroenterology & Urology · 54d
Cleared Feb 28, 2006
CRYOCARE CS SURGICAL SYSTEM
K060279 · GEH
Endocare, Inc.
General & Plastic Surgery · 26d
Cleared Feb 28, 2006
CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000
K060400 · GEI
Medtronic, Inc.
General & Plastic Surgery · 13d
Cleared Feb 27, 2006
LEONE IMPLANT SYSTEM
K050586 · DZE
Leone S.P.A.
Dental · 357d
Cleared Feb 27, 2006
GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES
K052665 · FRG
Granton Medical , Ltd.
General Hospital · 153d
Cleared Feb 27, 2006
SLACTIVE IMPLANTS
K053088 · DZE
Institut Straumann AG
Dental · 117d
Cleared Feb 27, 2006
DRLOCK DISTAL RADIUS VOLAR SYSTEM
K053182 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 105d
Cleared Feb 27, 2006
TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS
K053340 · MBH
Zimmer Trabecular
Orthopedic · 88d
Cleared Feb 27, 2006
AEROECLIPSE II BREATH ACTUATED NEBULIZER
K053605 · CAF
Trudell Medical Intl.
Anesthesiology · 62d
Cleared Feb 27, 2006
MIIG SR
K060011 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 55d