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
60817–60840 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2006
MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
K063497 · MAI
Scandius Biomedical, Inc.
Orthopedic · 29d
Cleared Dec 19, 2006
MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
K063499 · MBI
Scandius Biomedical, Inc.
Orthopedic · 29d
Cleared Dec 19, 2006
VISTA AVS
K063600 · JAF
Summit Doppler Systems, Inc.
Radiology · 15d
Cleared Dec 18, 2006
PROGENIX DBM PUTTY AND PASTE
K060794 · MBP
Medtronic Sofamor Danek
Orthopedic · 270d
Cleared Dec 18, 2006
SOMNOFIT
K060795 · LRK
Strategic Counsel Sarl
Dental · 270d
Cleared Dec 18, 2006
MOBIS SPINAL IMPLANT
K061082 · MQP
Signus Medizintechnik GmbH
Orthopedic · 244d
Cleared Dec 18, 2006
LOSS OF RESISTANCE SYRINGE
K061737 · CAZ
Robert Busse & Co., Inc.
Anesthesiology · 181d
Cleared Dec 18, 2006
QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA
K062929 · DIO
Quest Diagnostics, Inc.
Toxicology · 81d
Cleared Dec 18, 2006
BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS
K062971 · DJZ
Akers Biosciences, Inc.
Toxicology · 80d
Cleared Dec 18, 2006
SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM
K063049 · HRS
Synthes (Usa)
Orthopedic · 75d
Cleared Dec 18, 2006
LORENZ STERNAL CLOSURE SYSTEM
K063506 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 28d
Cleared Dec 18, 2006
KOWA SL-15
K063640 · HJO
Kowa Co. , Ltd.
Ophthalmic · 11d
Cleared Dec 15, 2006
BF+ (PH)
K061462 · MQV
Ldr Spine USA
Orthopedic · 203d
Cleared Dec 15, 2006
LASER-D68
K061656 · GEX
Laser Pain Clinics LP
General & Plastic Surgery · 189d
Cleared Dec 15, 2006
ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER
K061680 · DQY
Atrium Medical Corp.
Cardiovascular · 183d
Cleared Dec 15, 2006
SDI CA480 CLINICAL CHEMISTRY SYSTEM
K061879 · CFR
Hemodiagnostica, LLC
Chemistry · 165d
Cleared Dec 15, 2006
CERAMIC BOND
K062345 · EBF
Voco GmbH
Dental · 126d
Cleared Dec 15, 2006
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K062426 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 119d
Cleared Dec 15, 2006
VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE...
K062460 · DJG
Ortho-Clinical Diagnostics, Inc.
Chemistry · 114d
Cleared Dec 15, 2006
OSSPRAY CLEANING COMPOUND
K062502 · EJR
Ospray, Ltd.
Dental · 112d
Cleared Dec 15, 2006
OCTAX LASER SHOT SYSTEM
K062524 · MRX
Minitube of America, Inc.
Obstetrics & Gynecology · 109d
Cleared Dec 15, 2006
NEXUS IRRIGATION TUBING SET
K062551 · LJH
Nexus Medical, LLC
Gastroenterology & Urology · 107d
Cleared Dec 15, 2006
V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC
K062577 · DSA
Tz Medical, Inc.
Cardiovascular · 106d
Cleared Dec 15, 2006
SYNTHETIC VINYL PATIENT EXAM GLOVES, PRE-POWDERED, YELLOW
K062714 · LYZ
Baoding Guanzhong Glove Co., Ltd.
General Hospital · 95d