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
16969–16992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Jun 22, 2021
MolecuLight I:X
K210882 · QJF
Moleculight, Inc.
General & Plastic Surgery · 89d
Cleared Jun 22, 2021
SenoBright HD
K211215 · MUE
Ge Healthcare
Radiology · 60d
Cleared Jun 22, 2021
ICOONE Laser Med (also referred to as ICOONE Medical laser)
K211272 · NUV
I-Tech Industries Srl
General & Plastic Surgery · 56d
Cleared Jun 21, 2021
coDiagnostiX
K193301 · DZJ
Dental Wings GmbH
Dental · 570d
Cleared Jun 21, 2021
Posterior Spinal Fixation System
K201737 · NKB
Shanghai Reach Medical Instrument Co,...
Orthopedic · 361d
Cleared Jun 21, 2021
Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis...
K202085 · LZA
Shen Wei (Usa), Inc.
General Hospital · 329d
Cleared Jun 21, 2021
Orthodontic Facemask
K202855 · DZB
Ita.O Italian Orthodontic System S.R.L.
Dental · 266d
Cleared Jun 21, 2021
2430MCA with Xmaru W
K202902 · MUE
Rayence Co., Ltd.
Radiology · 265d
Cleared Jun 21, 2021
Powder Free Blue Nitrile Examination Glove
K210375 · LZA
Duramitt Sdn Bhd
General Hospital · 133d
Cleared Jun 21, 2021
7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D...
K210457 · OLO
7D Surgical, Inc.
Orthopedic · 125d
Cleared Jun 21, 2021
Straumann BLX Implant System
K210855 · DZE
Institut Straumann AG
Dental · 90d
Cleared Jun 21, 2021
Steri-Dot Process Indicator
K210866 · JOJ
Propper Manufacturing Co., Inc.
General Hospital · 90d
Cleared Jun 21, 2021
LINK Embrace Shoulder System- Anatomical Configuration
K210899 · KWT
Waldemar Link GmbH & Co. KG
Orthopedic · 87d
Cleared Jun 21, 2021
VisionPort System
K211250 · GCJ
New View Surgical, Inc.
General & Plastic Surgery · 56d
Cleared Jun 18, 2021
Transcutaneous Electrical Nerve Stimulator
K202893 · GZJ
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 263d
Cleared Jun 18, 2021
iBed Wireless with iBed Mobile
K202964 · FNL
Stryker Corporation
General Hospital · 261d
Cleared Jun 18, 2021
Kontact Dental Implant System
K210220 · DZE
Biotech Dental, Sas
Dental · 142d
Cleared Jun 18, 2021
Intravascular Extension Set
K210430 · FPA
Baxter Healthcare Corporation
General Hospital · 126d
Cleared Jun 18, 2021
Port Access System
K210495 · GCJ
Surgical Innovations Limited
General & Plastic Surgery · 116d
Cleared Jun 17, 2021
Restor3d Utility Wedge
K201314 · PLF
Restor3D, Inc.
Orthopedic · 395d
Cleared Jun 17, 2021
Su2ura Approximation Device
K201744 · OCW
Anchora Medical, Ltd.
General & Plastic Surgery · 357d
Cleared Jun 17, 2021
Infrared Thermometer
K202440 · FLL
Shenzhen Sonida Digital Technology...
General Hospital · 296d
Cleared Jun 17, 2021
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
K202806 · MAI
Osteonic Co., Ltd.
Orthopedic · 267d
Cleared Jun 17, 2021
Precise Position
K203514 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 199d