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
17545–17568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 2021
Omron Model BP7900 Blood Pressure Monitor + EKG
K202228 · DXN
Omron Healthcare, Inc.
Cardiovascular · 237d
Cleared Apr 01, 2021
Pentax Medical Video Duodenoscope ED32-i10
K202365 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 225d
Cleared Apr 01, 2021
KOSMO Femoral Stem
K202768 · LZO
B-One Ortho, Corp.
Orthopedic · 192d
Cleared Apr 01, 2021
Simpleware ScanIP Medical
K203195 · LLZ
Synopsys (Northern Europe) , Ltd.
Radiology · 155d
Cleared Apr 01, 2021
Nanox Cart X-ray System
K203782 · IZL
Nano-X Imaging , Ltd.
Radiology · 94d
Cleared Apr 01, 2021
Star RF Electrode, VIVA RF Electrode
K203795 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 94d
Cleared Apr 01, 2021
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens...
K210300 · LYL
Vuesonic, LLC
Ophthalmic · 57d
Cleared Apr 01, 2021
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit...
K210340 · LNH
Canon Medical Systems Corporation
Radiology · 55d
Cleared Apr 01, 2021
TSolution One Total Knee Application
K210668 · OLO
THINK Surgical, Inc.
Orthopedic · 27d
Cleared Apr 01, 2021
ACUSON Redwood Diagnostic Ultrasound System
K210743 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Mar 31, 2021
Myriad Particles
K200502 · KGN
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 397d
Cleared Mar 31, 2021
Digital Thermometer Model T103, T104
K201879 · FLL
Bioland Technology, Ltd.
General Hospital · 267d
Cleared Mar 31, 2021
Surgical Mask-Models CR02-2, CR02
K202424 · FXX
Foshan Xinbao Technology Co., Ltd.
General Hospital · 218d
Cleared Mar 31, 2021
Secure Wear USA Surgical Face Mask
K203101 · FXX
Secured Ortho Manufacturing of...
General Hospital · 168d
Cleared Mar 31, 2021
syngo.CT Lung CAD
K203258 · OEB
Siemens Healthcare GmbH
Radiology · 146d
Cleared Mar 31, 2021
Pulsehaler
K203378 · BWF
Respinova, Ltd.
Anesthesiology · 134d
Cleared Mar 31, 2021
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
K203443 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 128d
Cleared Mar 31, 2021
Blue Nitrile Exam Glove, Powder Free
K210057 · LZA
Real Star Medical Technology Co., Ltd.
General Hospital · 79d
Cleared Mar 31, 2021
SIS System (Version 5.1.0)
K210071 · LLZ
Surgical Information Sciences, Inc.
Radiology · 79d
Cleared Mar 31, 2021
Guidion
K210110 · DQY
Imds Operations B.V.
Cardiovascular · 71d
Cleared Mar 31, 2021
Longeviti PMMA Static Cranial Implant
K210616 · GXN
Longeviti Neuro Solutions, LLC
Neurology · 30d
Cleared Mar 31, 2021
Avitus(r) Bone Harvester
K210631 · KNW
Avitus Orthopaedics, Inc.
Orthopedic · 28d
Cleared Mar 31, 2021
EnCor Breast Biopsy Probe with Rinse Tube
K210654 · KNW
Senorx, Inc.
General & Plastic Surgery · 27d
Cleared Mar 30, 2021
Modulith SLX-F2
K201001 · LNS
Karl Storz Endoscopy America
Gastroenterology & Urology · 348d