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
37369–37392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 2014
ARTHREX ANKLE FUSION PLATING SYSTEM
K141735 · HRS
Arthrex, Inc.
Orthopedic · 49d
Cleared Aug 15, 2014
DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE
K141951 · DWF
Medtronic, Inc.
Cardiovascular · 28d
Cleared Aug 14, 2014
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
K130720 · KCT
Synthes USA Products, LLC
General Hospital · 514d
Cleared Aug 14, 2014
OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM
K132633 · NBW
Ok Biotech Co., Ltd.
Chemistry · 357d
Cleared Aug 14, 2014
TEMPUS PRO WITH ENHANCED FEATURES
K133973 · QYW
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 231d
Cleared Aug 14, 2014
SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT
K140232 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 196d
Cleared Aug 14, 2014
ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
K140508 · HRS
Zimmer, Inc.
Orthopedic · 167d
Cleared Aug 14, 2014
STRAUMANN CARES SCREW RETAINED BARS/BRIDGE
K140737 · NHA
Straumann USA, LLC
Dental · 143d
Cleared Aug 14, 2014
KIVA VCF TREATMENT SYSTEM
K141141 · NDN
Benvenue Medical, Inc.
Orthopedic · 104d
Cleared Aug 14, 2014
LIGASURE
K141153 · GEI
Covidien
General & Plastic Surgery · 101d
Cleared Aug 14, 2014
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
K141281 · KOC
Fresenius Medical Care Renal...
Gastroenterology & Urology · 90d
Cleared Aug 14, 2014
WHITNEY MEDICAL SOLUTIONS ESHIELD
K141438 · KKX
Whitney Medical Solutions
General Hospital · 76d
Cleared Aug 13, 2014
BUZZY
K130631 · PHW
Mmj Labs, LLC
Physical Medicine · 523d
Cleared Aug 13, 2014
0.9% SODIUM CHLORIDE FLUSH SYRINGE
K133685 · NGT
Am USA
General Hospital · 254d
Cleared Aug 13, 2014
3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER
K140392 · FRC
3M Company
General Hospital · 180d
Cleared Aug 13, 2014
ARTHREX FIBERTAK SUTURE ANCHOR
K140476 · MBI
Arthrex, Inc.
Orthopedic · 168d
Cleared Aug 13, 2014
ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST...
K140782 · NRB
Celleration, Inc.
General & Plastic Surgery · 135d
Cleared Aug 13, 2014
FINGERTIP PULSE OXIMETER
K141128 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 104d
Cleared Aug 13, 2014
ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES
K141517 · HRS
Zimmer, Inc.
Orthopedic · 65d
Cleared Aug 13, 2014
ZIMMER PERIARTICULAR LOCKING SYSTEM
K141734 · HRS
Zimmer, Inc.
Orthopedic · 47d
Cleared Aug 13, 2014
FIBERGRAFT BG MORSELS
K141956 · MQV
Prosidyan, Inc.
Orthopedic · 26d
Cleared Aug 12, 2014
BAHADIR STERILIZATION TRAYS
K131407 · KCT
Bahadir USA Corp.
General Hospital · 454d
Cleared Aug 12, 2014
ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS
K133255 · DZE
Dentalpoint AG
Dental · 293d
Cleared Aug 12, 2014
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE...
K133358 · HQF
Nidek Co., Ltd.
Ophthalmic · 285d