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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
46681–46704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2011
STREAMLINE TL SPINAL SYSTEM
K111502 · NKB
Pioneer Surgical Technology, Inc.
Orthopedic · 84d
Cleared Aug 23, 2011
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K111507 · OQW
Centers For Disease Control and...
Microbiology · 83d
Cleared Aug 23, 2011
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A...
K111589 · LZA
Derma Care Plus Products, LLC
General Hospital · 77d
Cleared Aug 23, 2011
SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE...
K111620 · HRS
Skeletal Dynamics, LLC
Orthopedic · 74d
Cleared Aug 23, 2011
INTEGRA(TM) CUSA NXT(TM) BONE TIPS
K111741 · LFL
Integra Burlington Ma, Inc. (Formerly...
General & Plastic Surgery · 63d
Cleared Aug 22, 2011
YOLO CURVE
K110342 · ILY
Yolo Medical, Inc.
Physical Medicine · 199d
Cleared Aug 22, 2011
ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE
K110584 · MOF
Asahi Intecc Co., Ltd.
Neurology · 174d
Cleared Aug 22, 2011
RELIEVA SOLO ELITE SINUS BALLOON CATHETER
K111254 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 110d
Cleared Aug 22, 2011
TALON DISTALFIX PROXIMAL FEMORAL NAIL
K111352 · HSB
Orthopedic Designs North America, Inc.
Orthopedic · 101d
Cleared Aug 22, 2011
BOSTON BAND
K111609 · MVA
Boston Brace Intl., Inc.
Neurology · 74d
Cleared Aug 19, 2011
LIPOSONIX SYSTEM, MODEL 1 P00XXXX
K100874 · OHV
Medicis Technologies Corporation
General & Plastic Surgery · 507d
Cleared Aug 19, 2011
STAXX XDL SYSTEM
K102315 · MQP
Spine Wave, Inc.
Orthopedic · 368d
Cleared Aug 19, 2011
CKMB UDR ASSAY
K102706 · JHS
SENTINEL CH. SpA
Chemistry · 333d
Cleared Aug 19, 2011
TRIMED RADIOCARPAL FUSION SYSTEM
K102785 · HRS
TriMed, Inc.
Orthopedic · 326d
Cleared Aug 19, 2011
RSI 4200
K102831 · CBF
Reimers Systems, Inc.
Anesthesiology · 324d
Cleared Aug 19, 2011
ELECTROTORQUE TLC
K103027 · EBW
Kaltenbach & Voigt GmbH
Dental · 310d
Cleared Aug 19, 2011
POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE
K103734 · LZA
Central Medicare Sdn Bhd
General Hospital · 240d
Cleared Aug 19, 2011
SONAFINE WOUND DRESSING
K110172 · FRO
Stratus Pharmaceutical
General & Plastic Surgery · 211d
Cleared Aug 19, 2011
SILK'N FX
K110301 · OHS
Home Skinovations , Ltd.
General & Plastic Surgery · 198d
Cleared Aug 19, 2011
INFOSEND GSM
K110316 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 197d
Cleared Aug 19, 2011
INBODY
K110689 · MNW
Biospace Corporation Limited
Gastroenterology & Urology · 157d
Cleared Aug 19, 2011
TL-CERMIDE SKIN BARRIER EMULSION
K110757 · FRO
Trigen Laboratories, Inc.
General & Plastic Surgery · 154d
Cleared Aug 19, 2011
V200 INTELLI-TRAK OPTION
K110795 · CBK
Respironics California, Inc.
Anesthesiology · 150d
Cleared Aug 19, 2011
BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
K110879 · MBI
Biomet Sports Medicine
Orthopedic · 142d