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
33217–33240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2015
Pacifier Activated Lullaby (PAL®)
K151050 · HCC
Power Medical Devices, LLC
Neurology · 246d
Cleared Dec 22, 2015
Magnetic Reasonance Imaging System
K151074 · LNH
Jiangsu Magspin Instrument Co.,Ltd
Radiology · 244d
Cleared Dec 22, 2015
Nexodyn AOS Wound Care Solution
K151168 · FRO
Apr Applied Pharma Research SA
General & Plastic Surgery · 235d
Cleared Dec 22, 2015
MammoGRIP
K152038 · IZH
Women'S Imaging Solutions...
Radiology · 153d
Cleared Dec 22, 2015
PRECICE Trauma Nail System
K152370 · HSB
Ellipse Technologies, Incorporated
Orthopedic · 123d
Cleared Dec 22, 2015
Rectangular Corpectomy Cage
K152460 · MQP
Amendia, Inc.
Orthopedic · 116d
Cleared Dec 22, 2015
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
K152852 · NUH
Bayer Healthcare, LLC
Neurology · 84d
Cleared Dec 22, 2015
Philips Eleva Workspot with SkyFlow
K153318 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 34d
Cleared Dec 22, 2015
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install...
K153369 · IYO
Volcano Corporation
Radiology · 29d
Cleared Dec 21, 2015
Dario Blood Glucose Monitoring System
K150817 · NBW
Labstyle Innovations, Ltd.
Chemistry · 269d
Cleared Dec 21, 2015
HydroPearl Microspheres, HydroPearl Microspheres
K150870 · KRD
MicroVention, Inc.
Cardiovascular · 264d
Cleared Dec 21, 2015
Powder Free Vinyl Patient Examination Glove (Non?-Sterile)
K150934 · LYZ
Lpl (Hui Zhou) Glove
General Hospital · 259d
Cleared Dec 21, 2015
FreezeKit Cleave , ThawKit Cleave
K150950 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 257d
Cleared Dec 21, 2015
Electric Double Breast Pumps
K151284 · HGX
Wuxi Xinzhongrui Baby Supplies Co., Ltd.
Obstetrics & Gynecology · 221d
Cleared Dec 21, 2015
Cardinal Health Sterilization Wrap
K151445 · FRG
Cardinal Health200, LLC
General Hospital · 206d
Cleared Dec 21, 2015
Sahara Stabilization System
K151481 · OVD
K2m, Inc.
Orthopedic · 202d
Cleared Dec 21, 2015
Cerner CareAware Event Management
K151672 · MSX
Cerner Corporation
Cardiovascular · 182d
Cleared Dec 21, 2015
SERVO-U Ventilator System, SERVO-n Ventilator System
K151814 · CBK
Maquet Critical Care AB
Anesthesiology · 168d
Cleared Dec 21, 2015
OsteoMed ExtremiLOCK Wrist Plating System
K152145 · HRS
Osteomed
Orthopedic · 140d
Cleared Dec 21, 2015
AXI+LINE Proximal Bunion Correction System
K152548 · HRS
Nextremity Solutions, Inc.
Orthopedic · 104d
Cleared Dec 21, 2015
Powder Free Vinyl Patient Examination Gloves (Green)
K152692 · LYZ
Supermax Plastic Products Co., Ltd.
General Hospital · 91d
Cleared Dec 21, 2015
Quanta Forte
K152714 · GEX
Quanta System Spa
General & Plastic Surgery · 91d
Cleared Dec 21, 2015
FastFrame External Fixation System-Ankle Spanning
K152755 · KTT
Zimmer, Inc.
Orthopedic · 88d
Cleared Dec 21, 2015
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K152774 · JWY
Thermo Fisher Scientific
Microbiology · 87d