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
15769–15792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 2021
SoftFix Balloon Trocar
K211577 · GCJ
Unimax Medical Systems, Inc.
General & Plastic Surgery · 168d
Cleared Nov 05, 2021
Acuson SC2000 Diagnostic Ultrasound System
K211726 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 154d
Cleared CT Nov 05, 2021
Anterion
K211817 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 147d
Cleared Nov 05, 2021
Drug Relief v1
K211971 · PZR
Dyansys, Inc.
Neurology · 134d
Cleared Nov 05, 2021
TrueLok Evo
K212044 · KTT
Orthofix Srl
Orthopedic · 128d
Cleared Nov 05, 2021
Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))
K212460 · FXX
Guangzhou Zhengkang Medical Equipment...
General Hospital · 92d
Cleared Nov 05, 2021
Disposable Nitrile Examination gloves
K212485 · LZA
Fujian Yuanxin Safety Protection...
General Hospital · 88d
Cleared Nov 05, 2021
Resonic Rapid Acoustic Pulse Device
K212502 · GEX
Soliton, Inc.
General & Plastic Surgery · 88d
Cleared Nov 05, 2021
VFSS Pro Mobile Digital Imaging System
K212523 · OWB
Imagexray, LLC
Radiology · 86d
Cleared Nov 05, 2021
Nitrile Examination Gloves
K212551 · LZA
Anhui Fine Glove Medical Technology...
General Hospital · 84d
Cleared Nov 05, 2021
CoolSculpting Elite System
K212707 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 71d
Cleared Nov 05, 2021
Cervical Stand-Alone System
K212853 · OVE
Eminent Spine, LLC
Orthopedic · 59d
Cleared Nov 05, 2021
Visible Patient Suite
K212896 · LLZ
Visible Patient, Sas
Radiology · 56d
Cleared Nov 05, 2021
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic...
K212900 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 53d
Cleared Nov 04, 2021
CARESCAPE R860
K210384 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 268d
Cleared Nov 04, 2021
X-FLO Fluid Management System
K210628 · HIG
Thermedx, LLC
Obstetrics & Gynecology · 247d
Cleared Nov 04, 2021
Powder Free Vinyl Examination Gloves
K211103 · LYZ
Shanghai Shengda Medical Applications...
General Hospital · 205d
Cleared Nov 04, 2021
Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B
K211288 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 190d
Cleared Nov 04, 2021
Comprehensive® Convertible Glenoid - Vivacit-E Liner
K211729 · PHX
Biomet Manufacturing Corp
Orthopedic · 153d
Cleared Nov 04, 2021
Blood Collection Needle for Single Use & Blood Collection Needle with Holder...
K212019 · JKA
Jiangsu Micsafe Medical Technology...
General Hospital · 129d
Cleared Nov 04, 2021
Disposable Nitrile Examination Glove
K212467 · LZA
Inner Mongolia Boming Medical...
General Hospital · 90d
Cleared Nov 04, 2021
Medical Face Mask
K212471 · FXX
Haian Medigauze Co., Ltd.
General Hospital · 90d
Cleared Nov 04, 2021
Ortho Aligner System
K212496 · NXC
Ortho Lab Services, LLC
Dental · 87d
Cleared Nov 04, 2021
7 Series Phototherapy Device
K212510 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 86d