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
30601–30624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2016
Non-contact Forehead Thermometer
K161735 · FLL
Shenzhen Dongdixin Technology Co., Ltd.
General Hospital · 147d
Cleared Nov 17, 2016
Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler,...
K161905 · GDW
Changzhou Xin Neng Yuan Medical...
General & Plastic Surgery · 129d
Cleared Nov 17, 2016
IQvitals Zone
K161909 · MWI
Midmark Corporation
Cardiovascular · 128d
Cleared Nov 17, 2016
Avance Abdominal Dressing Kit
K161939 · OXJ
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 126d
Cleared Nov 17, 2016
AirFit N20
K161978 · BZD
Resmed, Ltd.
Anesthesiology · 122d
Cleared Nov 17, 2016
InTRAkit
K162097 · DYB
Medtronic Vascular
Cardiovascular · 111d
Cleared CT Nov 17, 2016
UltraShape System
K162163 · OHV
Syneron Medical, Ltd.
General & Plastic Surgery · 107d
Cleared Nov 17, 2016
MOSS 100 Pedicle Screw System
K162232 · NKB
Biedermann Motech GmbH & Co. KG
Orthopedic · 101d
Cleared Nov 17, 2016
ProMedTek Model C1400 Shortwave Diathermy Device
K162240 · IMJ
Promedtek, Inc.
Physical Medicine · 100d
Cleared Nov 17, 2016
the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
K162322 · DYB
Access Scientific, LLC
Cardiovascular · 90d
Cleared Nov 17, 2016
Luna 3D Interbody Fusion System
K162431 · MAX
Benvenue Medical, Inc.
Orthopedic · 78d
Cleared Nov 17, 2016
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI)...
K162538 · JIT
Siemens Healthcare Diagnostics
Chemistry · 66d
Cleared Nov 17, 2016
ALOKA LISENDO 880
K162583 · IYN
Hitachi , Ltd.
Radiology · 63d
Cleared Nov 17, 2016
Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6)...
K162843 · DWB
Terumo Cardiovascular Systems...
Cardiovascular · 37d
Cleared Nov 17, 2016
LOGIQ E9, LOGIQ E9 XDClear 2.0
K163077 · IYN
GE Medical Systems Ultrasound and...
Radiology · 14d
Cleared Nov 16, 2016
Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)
K160663 · MAX
Evolution Spine, LLC
Orthopedic · 252d
Cleared Nov 16, 2016
DuoCem
K160800 · EMA
Coltene/Whaledent AG
Dental · 238d
Cleared Nov 16, 2016
LenSX Laser System
K161288 · OOE
Alcon Laboratories, Inc.
Ophthalmic · 191d
Cleared Nov 16, 2016
Tyber Medical BioTy® Nanotopography Trauma Screw
K161597 · HWC
Tyber Medical, LLC
Orthopedic · 160d
Cleared Nov 16, 2016
Diode Laser Therapy Machine
K161692 · GEX
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 149d
Cleared Nov 16, 2016
Aixplorer
K161999 · IYN
Supersonic Imagine
Radiology · 119d
Cleared Nov 16, 2016
touchTymp
K162210 · ETY
Maico Diagnostics GmbH
Ear, Nose, Throat · 103d
Cleared Nov 16, 2016
iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert
K162231 · OHT
Cyden Limited
General & Plastic Surgery · 100d
Cleared Nov 16, 2016
CD HORIZON® Spinal System
K162379 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 84d