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

Filters: Cleared only ×
175,820 results
34801–34824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 2015
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista...
K140790 · JIX
Siemens Healthcare Diagnostics
Chemistry · 441d
Cleared Jun 15, 2015
Chang Gung ComMed Series Dental Implant System
K142751 · DZE
Chang Gung Medical Technology Co., Ltd.
Dental · 264d
Cleared Jun 15, 2015
LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID
K143090 · EIH
Talladium, Inc.
Dental · 230d
Cleared Jun 15, 2015
Dymaxeon Spine System
K150184 · NKB
Back 2 Basics Direct, LLC
Orthopedic · 139d
Cleared Jun 15, 2015
Neodent Implant System
K150199 · DZE
Jjgc Industria E Comercio DE...
Dental · 137d
Cleared Jun 15, 2015
XXL Vascular Balloon Dilatation Catheter
K150303 · LIT
Boston Scientific Corp
Cardiovascular · 129d
Cleared Jun 15, 2015
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for...
K150630 · MVN
Yung Sheng Optical Co., Ltd.
Ophthalmic · 96d
Cleared Jun 12, 2015
BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM
K141943 · CBK
Breathe Technologies
Anesthesiology · 330d
Cleared Jun 12, 2015
Luma Wrap
K142416 · PDH
Salter Labs
General Hospital · 288d
Cleared Jun 12, 2015
Opto Wire and OptoMonitor System
K142598 · DQX
Opsens, Inc.
Cardiovascular · 270d
Cleared Jun 12, 2015
Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing...
K142626 · OMP
Medela AG
General & Plastic Surgery · 269d
Cleared Jun 12, 2015
CARESCAPE R860
K142679 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 266d
Cleared Jun 12, 2015
HEARTWAY Electrically Powered Wheelchair P27
K142783 · ITI
Heartway Medical Products Co., Ltd.
Physical Medicine · 259d
Cleared Jun 12, 2015
Iliad Pedicle Screw System and Zenius Pedicle Screw System
K142835 · NKB
Medyssey USA, Inc.
Orthopedic · 255d
Cleared Jun 12, 2015
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S
K150080 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 148d
Cleared Jun 12, 2015
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH...
K150319 · HCG
Codman & Shurtleff, Inc.
Neurology · 123d
Cleared Jun 12, 2015
Sonoma Cancellous Bone Screw and Washer
K150376 · HWC
Sonoma Orthopedics Products, Inc.
Orthopedic · 119d
Cleared Jun 12, 2015
NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
K150378 · GZT
Nico Corporation
Neurology · 119d
Cleared Jun 12, 2015
Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model...
K150414 · LZA
Industrial Clothings (Pvt), Ltd.
General Hospital · 114d
Cleared Jun 12, 2015
NilRead
K150415 · LLZ
Perceptive Software
Radiology · 114d
Cleared Jun 12, 2015
Total Knee Arthroplasty System
K150496 · JWH
Responsive Orthopedics, LLC
Orthopedic · 107d
Cleared Jun 12, 2015
Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
K150582 · NDN
Stryker Corporation
Orthopedic · 95d
Cleared Jun 12, 2015
Trevo XP ProVue Retriever (4x30mm)
K150616 · NRY
Concentric Medical, Inc.
Neurology · 94d
Cleared Jun 12, 2015
Wi-3 HAL-RAR System
K150718 · FHN
Agency For Medical Innovations GmbH
Gastroenterology & Urology · 85d