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
34489–34512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 2015
PATHWAY ELIF
K143143 · MAX
Custom Spine, Inc.
Orthopedic · 261d
Cleared Jul 22, 2015
TM-ABI system
K143152 · JOM
Ld Technology, LLC
Cardiovascular · 261d
Cleared Jul 22, 2015
Powder-Free White Vinyl Patient Examination Gloves
K143346 · LYZ
Zibo Changda Plastic Products...
General Hospital · 243d
Cleared Jul 22, 2015
Nutra Light Advanced
K150370 · OLP
Nutra Luxe MD, LLC
General & Plastic Surgery · 159d
Cleared Jul 22, 2015
Zeramic Adhesive Resin Cement
K150601 · EMA
Premier Dental Company Products
Dental · 134d
Cleared Jul 22, 2015
LaserCap LC Pro and LC Elite
K150613 · OAP
Transdermal Cap, Inc.
General & Plastic Surgery · 134d
Cleared Jul 22, 2015
Cordelle II Sound Processor
K150751 · LXB
Cochlear Americas
Ear, Nose, Throat · 121d
Cleared CT Jul 22, 2015
iFuse Implant System
K150875 · OUR
SI-BONE, Inc.
Orthopedic · 112d
Cleared Jul 22, 2015
Rampart-T Interbody Fusion System
K151020 · MAX
Spineology, Inc.
Orthopedic · 97d
Cleared Jul 22, 2015
Ventilation (Tympanostomy) Tubes
K151067 · ETD
Medtronic Xomed, Inc.
Ear, Nose, Throat · 92d
Cleared Jul 22, 2015
CoSense ETCO Monitor
K151107 · CCJ
Capnia, Inc.
Anesthesiology · 86d
Cleared Jul 22, 2015
ELITech Clinical Systems CALCIUM ARSENAZO
K151113 · CJY
Elitechgroup
Chemistry · 86d
Cleared Jul 22, 2015
Retracta Detachable Embolization Coil
K151676 · KRD
Cook Incorporated
Cardiovascular · 30d
Cleared Jul 21, 2015
DENTCA DENTURE BASE
K143033 · EBI
Dentca, Inc.
Dental · 272d
Cleared Jul 21, 2015
TENS AND POWERED MUSCLE STIMULATOR
K143268 · NUH
Shenzhen As-Tec Technology Co., Ltd.
Neurology · 250d
Cleared Jul 21, 2015
NovoStitch Plus Meniscal Repair System
K143356 · GAT
Ceterix Orthopaedics, Inc.
General & Plastic Surgery · 239d
Cleared Jul 21, 2015
CooperSurgical Advincula Delineator Uterine Manipulator
K143650 · HEW
CooperSurgical, Inc.
Obstetrics & Gynecology · 210d
Cleared Jul 21, 2015
Flexi-Seal Signal Fecal Management System
K150350 · KNT
Convatec, Ltd.
Gastroenterology & Urology · 160d
Cleared CT Jul 21, 2015
Cloud9 System
K150365 · BZD
Insleep Technologies, LLC
Anesthesiology · 159d
Cleared Jul 21, 2015
MiNi Internal Implant System
K150537 · DZE
Megagen Implant Co., Ltd.
Dental · 140d
Cleared Jul 21, 2015
Cortex Laser System
K150587 · GEX
Cynosure, Inc. Dba Ellman
General & Plastic Surgery · 134d
Cleared Jul 21, 2015
PulseRelief
K151035 · NUH
Philips Consumer Lifestyle
Neurology · 95d
Cleared Jul 21, 2015
Mosaic Universal Composite
K151094 · EBF
Ultradent Products, Inc.
Dental · 89d
Cleared Jul 21, 2015
Caiman Seal and Cut Technology
K151858 · GEI
Aesculap, Inc.
General & Plastic Surgery · 13d