FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
30553–30576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2016
Evolv Model BP7000 Upper Arm Blood Pressure Monitor
K162092 · DXN
Omron Healthcare, Inc.
Cardiovascular · 117d
Cleared Nov 22, 2016
MAGNETOM Avantofit, MAGNETOM Skyrafit
K162102 · LNH
Siemens Medi Cal Solutions, Inc.
Radiology · 116d
Cleared Nov 22, 2016
NAVILAS Laser System
K162191 · GEX
Od-Os GmbH
General & Plastic Surgery · 110d
Cleared Nov 22, 2016
Pain Freeze™, Medium Stream Spray, Model #2101
K162218 · MLY
Nuance Medical, LLC
Physical Medicine · 106d
Cleared Nov 22, 2016
WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System
K162225 · MRZ
Welldoc, Inc.
General Hospital · 106d
Cleared Nov 22, 2016
Reform® POCT System
K162300 · NKG
Precision Spine, Inc.
Orthopedic · 98d
Cleared Nov 22, 2016
Pirouette 014
K162316 · LIT
Arravasc, Ltd.
Cardiovascular · 96d
Cleared Nov 22, 2016
Raycast MammoRx Carbon Fibre Breast Board
K162355 · IYE
Orfit Industries NV
Radiology · 91d
Cleared Nov 22, 2016
ViewPoint 6
K162743 · LLZ
GE Medical Systems Ultrasound and...
Radiology · 53d
Cleared Nov 22, 2016
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter,...
K162970 · QEW
Inari Medical
Cardiovascular · 29d
Cleared Nov 22, 2016
Multix Fusion Max
K162971 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Nov 21, 2016
Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment...
K160132 · NHA
Hager& Meisinger GmbH
Dental · 306d
Cleared Nov 21, 2016
Electronic Pulse Stimulator
K160508 · NUH
Beijing Choice Electronic Technololgy...
Neurology · 271d
Cleared Nov 21, 2016
CorSens
K160656 · DXR
Corsens Medical , Ltd.
Cardiovascular · 258d
Cleared Nov 21, 2016
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c...
K160762 · LCP
Diazyme Laboratories
Chemistry · 245d
Cleared CT Nov 21, 2016
RODO Abutment System
K160786 · NHA
Rodo Medical, Inc.
Dental · 244d
Cleared Nov 21, 2016
XEN Glaucoma Treatment System
K161457 · KYF
Allergan, Inc.
Ophthalmic · 179d
Cleared Nov 21, 2016
SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G...
K161700 · OWQ
Sterilmed, Inc.
Cardiovascular · 154d
Cleared Nov 21, 2016
Arthrex Univers Revers Shoulder Prosthesis System
K161782 · HSD
Arthrex, Inc.
Orthopedic · 145d
Cleared Nov 21, 2016
HC Primer
K161891 · KLE
Shofu Dental Corporation
Dental · 133d
Cleared Nov 21, 2016
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and...
K161944 · LZA
Shandong Baisheng Medical Products...
General Hospital · 129d
Cleared Nov 21, 2016
AltiVate Anatomic Shoulder System
K162024 · KWS
Encore Medical, L.P.
Orthopedic · 122d
Cleared CT Nov 21, 2016
ZELTIQ CoolSculpting System
K162050 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 119d
Cleared Nov 21, 2016
Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2...
K162175 · LYY
Vietglove Corporation
General Hospital · 110d