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

Filters: Cleared only ×
175,820 results
18337–18360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2020
COOLIEF Cooled Radiofrequency Kit Advanced
K203066 · GXI
Avanos Medical, Inc.
Neurology · 74d
Cleared Dec 22, 2020
Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X
K203281 · OWB
Medphoton GmbH
Radiology · 46d
Cleared Dec 22, 2020
Serranator PTA Serration Balloon Catheter
K203437 · PNO
Cagent Vascular, LLC
Cardiovascular · 29d
Cleared Dec 22, 2020
iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal...
K203447 · JWH
Conformis, Inc.
Orthopedic · 29d
Cleared Dec 22, 2020
Nano FortiFix® System
K203452 · NKB
Nanovis, LLC
Orthopedic · 29d
Cleared Dec 22, 2020
CAPERE Thrombectomy System
K203476 · QEW
Vascular Medcure, Inc.
Cardiovascular · 27d
Cleared Dec 22, 2020
Cios Flow
K203504 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Dec 22, 2020
Rapid Reboot
K203552 · IRP
Rapid Reboot Recovery Products, LLC
Physical Medicine · 18d
Cleared Dec 21, 2020
Wu's Electrical Scooter
K192308 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 483d
Cleared Dec 21, 2020
Resascope RS-01/B
K201113 · HRX
Advanced Medical Systems Group Srl
Orthopedic · 238d
Cleared Dec 21, 2020
Monocryl Plus Antibacterial Suture
K201996 · GAM
Ethicon, Inc.
General & Plastic Surgery · 154d
Cleared Dec 21, 2020
num Vapocoolant
K202782 · MLY
623 Medical, LLC
Physical Medicine · 90d
Cleared Dec 21, 2020
MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer...
K202979 · ISD
Lode B.V.
Physical Medicine · 82d
Cleared Dec 21, 2020
Trigon HA Stand-Alone Wedge Fixation System
K203445 · PLF
Nvision Biomedical Technologies, Inc.
Orthopedic · 28d
Cleared Dec 20, 2020
Strados Remote Electronic Stethoscope Platform (RESP)
K201077 · DSH
Strados Labs
Anesthesiology · 242d
Cleared Dec 20, 2020
Flexitouch Plus System
K203178 · JOW
Tactile Systems Technology, Inc. (Dba...
Cardiovascular · 55d
Cleared Dec 19, 2020
NovoFine Plus 32G Tip x 4 mm
K202005 · FMI
Novo Nordisk, Inc.
General Hospital · 151d
Cleared Dec 19, 2020
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove,...
K202668 · KGO
Medline Industries, Inc.
General Hospital · 96d
Cleared Dec 18, 2020
Fever Garde
K191978 · FLL
Hubdic Co., Ltd.
General Hospital · 513d
Cleared Dec 18, 2020
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV...
K201075 · FOZ
Becton, Dickinson and Company
General Hospital · 240d
Cleared Dec 18, 2020
microINR System
K201185 · GJS
Iline Microsystems, S.L.
Hematology · 231d
Cleared Dec 18, 2020
SQuEEZ Software
K201250 · LLZ
Cardiowise, Inc.
Radiology · 221d
Cleared Dec 18, 2020
EchoGo Pro
K201555 · POK
Ultromics, Ltd.
Radiology · 191d
Cleared Dec 18, 2020
LacriJet®
K201606 · OKS
Fci (France Chirurgie...
Ophthalmic · 186d