Search FDA 510(k) Database

7,059 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
19921–19944 of 174,061
Cleared Oct 31, 2019
StimRouter Neuromodulation System
K190047 · GZF
Bioness, Inc.
Neurology · 295d
Cleared Oct 31, 2019
Ultrasonic Surgical System
K190281 · LFL
Medisonic Technology CO
General & Plastic Surgery · 262d
Cleared Oct 31, 2019
Claritag
K190747 · GEH
Dgi Technologies
General & Plastic Surgery · 223d
Cleared Oct 31, 2019
OR3O Dual Mobility System
K191002 · LPH
Smith & Nephew, Inc.
Orthopedic · 198d
Cleared Oct 31, 2019
ePM Series Patient monitors
K191769 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 122d
Cleared Oct 31, 2019
Belimed Steam Sterilizer MST-H TOP 5000
K191896 · FLE
Belimed AG
General Hospital · 108d
Cleared Oct 31, 2019
Vitek Densichek
K192110 · LON
bioMerieux, Inc.
Microbiology · 87d
Cleared Oct 31, 2019
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
K192345 · JWY
Liofilchem S. R. L.
Microbiology · 63d
Cleared Oct 31, 2019
087 Balloon Guide Catheter System
K192525 · DQY
Q'Apel Medical, LLC
Neurology · 48d
Cleared Oct 31, 2019
VisionX 2.4
K192743 · LLZ
Durr Dental SE
Radiology · 31d
Cleared Oct 31, 2019
Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)
K192867 · GEI
Bovie Medical Corporation Dba Apyx...
General & Plastic Surgery · 24d
Cleared Oct 31, 2019
ADH19
K192961 · KLE
3M Deutschland GmbH
Dental · 9d
Cleared Oct 30, 2019
EZE SIT Valvulotome
K190267 · MGZ
Lemaitre Vascular
Cardiovascular · 264d
Cleared Oct 30, 2019
Arthrex Low Profile Screws
K190921 · HWC
Arthrex, Inc.
Orthopedic · 204d
Cleared Oct 30, 2019
IB3D ALIF
K191134 · MAX
Medicrea International SA
Orthopedic · 184d
Cleared Oct 30, 2019
Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology...
K191170 · NLH
Innovative Health, LLC
Cardiovascular · 182d
Cleared Oct 30, 2019
Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
K191264 · OQY
Ujenzi Charitable Trust
Obstetrics & Gynecology · 173d
Cleared Oct 30, 2019
Okami Medical LOBO Vascular Occlusion System
K192083 · KRD
Okami Medical
Cardiovascular · 89d
Cleared Oct 30, 2019
Treace Medical Concepts (TMC) Plating System
K192504 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 48d
Cleared Oct 30, 2019
Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and...
K192775 · PJB
Stereotaxis, Inc.
Cardiovascular · 30d
Cleared Oct 30, 2019
Aristotle 24 Guidewire, 200cm, Soft Profile
K192783 · DQX
Scientia Vascular, LLC
Neurology · 30d
Cleared Oct 30, 2019
Atellica IM Total hCG (ThCG)
K192790 · DHA
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Oct 29, 2019
BRILLIANT COMPONEER
K191385 · EBF
Coltene/Whaledent AG
Dental · 159d
Cleared Oct 29, 2019
EmFace Device
K191855 · PBX
Inmode MD , Ltd.
General & Plastic Surgery · 111d