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
16777–16800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 2021
Bio-Medicus Life Support Catheter and Introducer
K201100 · DWF
Medtronic, Inc.
Cardiovascular · 447d
Cleared Jul 15, 2021
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K201328 · QBJ
Dexcom, Inc.
Chemistry · 422d
Cleared Jul 15, 2021
Pain Therapy Device
K202638 · NGX
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine · 307d
Cleared Jul 15, 2021
TERA HARZ
K202846 · EBF
Graphy, Inc.
Dental · 293d
Cleared Jul 15, 2021
ReCross
K210431 · DQY
Imds Operations B.V.
Cardiovascular · 153d
Cleared Jul 15, 2021
Acumed Clavicle Hook Plating System
K210750 · HRS
Acumed, LLC
Orthopedic · 125d
Cleared Jul 15, 2021
Disposable Procedural Ear-loop Face Mask
K211042 · FXX
Changzhou Dsb Medical Co., Ltd.
General Hospital · 98d
Cleared Jul 15, 2021
Longeviti PorousFit implant
K211514 · KKY
Longeviti Neuro Solutions, LLC
General & Plastic Surgery · 59d
Cleared Jul 15, 2021
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K211547 · LZA
Edma Group, LLC
General Hospital · 57d
Cleared Jul 15, 2021
EleVation Breast Biopsy System
K211933 · KNW
Bard Peripheral Vascular
General & Plastic Surgery · 23d
Cleared Jul 14, 2021
N Latex FLC kappa, N Latex FLC lambda
K193047 · DFH
Siemens Healthcare Diagnostics...
Immunology · 621d
Cleared Jul 14, 2021
Infrared light therapy led facial light therapy mask-Derma plus, Photons...
K200983 · OHS
Ningbo Hesi Electric Co., Ltd.
General & Plastic Surgery · 456d
Cleared Jul 14, 2021
Provident II Hip Stems
K201733 · LPH
Globus Medical, Inc.
Orthopedic · 384d
Cleared Jul 14, 2021
Surgical Face Mask, Surgical Mask
K201844 · FXX
Lear Corporation
General Hospital · 373d
Cleared Jul 14, 2021
EliA SmDP-S
K202067 · LKP
Phadia AB
Immunology · 352d
Cleared Jul 14, 2021
NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
K202304 · PZM
Nyu Langone Medical Center
Pathology · 334d
Cleared Jul 14, 2021
Aduro Light Beauty Mask
K202390 · OHS
Shenzhen Kaiyan Medical CO , Ltd.
General & Plastic Surgery · 327d
Cleared Jul 14, 2021
OsteoSync™ Ti Dental Mesh
K202918 · JEY
Sites Medical, LLC
Dental · 288d
Cleared Jul 14, 2021
Myopia Master
K202989 · MXK
Oculus Optikger?te GmbH
Ophthalmic · 287d
Cleared Jul 14, 2021
Pisces Spinal System
K203023 · NKB
Ortho Development Corporation
Orthopedic · 285d
Cleared Jul 14, 2021
ARVIS Surgical Navigation System
K203115 · OLO
Insight Medical Systems, Inc.
Orthopedic · 271d
Cleared Jul 14, 2021
Nexo-Gide Bilayer Collagen Membrane
K203496 · FTM
Geistlich Pharma AG
General & Plastic Surgery · 229d
Cleared Jul 14, 2021
SMART FINDER
K203509 · IZH
Ims Giotto S.P.A.
Radiology · 226d
Cleared Jul 14, 2021
Darwin
K203728 · GEX
Luvo Medical Technologies, Inc.
General & Plastic Surgery · 205d