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
30937–30960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 2016
I.B.S. 2.0 Osteosynthesis screw
K160174 · HWC
In2bones Sas
Orthopedic · 253d
Cleared Oct 06, 2016
uVue HSG/SHG Catheter
K160217 · LKF
Cook Incorporated
Obstetrics & Gynecology · 251d
Cleared Oct 06, 2016
SimulCare II(TM)
K160246 · GZJ
Xanacare Technologies, LLC
Neurology · 248d
Cleared Oct 06, 2016
iSR'obot MRI-US Fusion
K161109 · LLZ
Biobot Surgical Pte., Ltd.
Radiology · 169d
Cleared Oct 06, 2016
Pour Acrylic
K161330 · EBI
Dentsply Sirona
Dental · 147d
Cleared Oct 06, 2016
HydroSet XT
K161447 · MQV
Orthovita, Inc.
Orthopedic · 134d
Cleared Oct 06, 2016
MR Syringe Dual Pack for Solaris Injectors
K161471 · DXT
Coeur, Inc.
Cardiovascular · 132d
Cleared Oct 06, 2016
ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
K161584 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 120d
Cleared Oct 06, 2016
Quantum LB
K161684 · DYH
Reliance Orthodontic Products, Inc.
Dental · 111d
Cleared Oct 06, 2016
CuattroDR
K161937 · KPR
Cuattro, LLC
Radiology · 84d
Cleared Oct 06, 2016
Ziehm Solo FD
K161976 · OWB
Ziehm Imaging GmbH
Radiology · 80d
Cleared Oct 06, 2016
Sapphire NC Plus
K162209 · LOX
Orbusneich Medical, Inc.
Cardiovascular · 62d
Cleared Oct 06, 2016
1012WCC, 1012WGC
K162518 · MQB
Rayence Co., Ltd.
Radiology · 27d
Cleared Oct 06, 2016
1717WCC / 1717WGC
K162519 · MQB
Rayence Co., Ltd.
Radiology · 27d
Cleared Oct 06, 2016
Viveve System
K162547 · GEI
Viveve, Inc.
General & Plastic Surgery · 24d
Cleared Oct 05, 2016
Painmaster MCT Patch
K151995 · NUH
Newmark, Inc.
Neurology · 443d
Cleared Oct 05, 2016
R:GEN Laser System
K153769 · HQF
Lutronic Corporation
Ophthalmic · 280d
Cleared Oct 05, 2016
ALADDIN HW3.0
K160327 · HJO
Visia Imaging S.R.L.
Ophthalmic · 243d
Cleared Oct 05, 2016
Dentiq3D
K160666 · LLZ
3D Industrial Imaging Co., Ltd.
Radiology · 210d
Cleared Oct 05, 2016
e-fix E35/E36
K161241 · ITI
Alber GmbH
Physical Medicine · 156d
Cleared Oct 05, 2016
R2 Dermal Cooling System
K161480 · GEH
R2 Dermatology
General & Plastic Surgery · 127d
Cleared Oct 05, 2016
Fingertip Pulse Oximeter MD300CN310
K161560 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 121d
Cleared CT Oct 05, 2016
The Cellfina System
K161885 · OUP
Ulthera, Inc.
General & Plastic Surgery · 86d
Cleared Oct 05, 2016
CO2 Laser Therapy Machine
K161925 · GEX
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 84d