510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
Ht Medical D.B.A. Xenix Medical
HD+12, HD+15
Cardioline S.P.A
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
Prevest Denpro Limited
CO2 Laser Machine (Lume)
Nanjing Bestview Laser S&T Co., Ltd.
ME-APDS; MAGENTIQ-COLO
Magentiq Eye, Ltd.
FaceHeart Vitals Software Development Kit (FH vitals SDK)
Faceheart Corp.
Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
Datex-Ohmeda, Inc.
Smartxide Tetra Pro
El.En S.P.A.
APRO 55 Catheter and Alembic Aspiration Tubing
Alembic, LLC
Disposable Medical Nitrile Examination Gloves (Non sterile)
Jiangsu Nanfang Medical Co., Ltd.
AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup
Hangzhou AllTest Biotech Co., Ltd.
LED Therapy Device (Planar LED/Planar LED mini)
Shenzhen Leaflife Technology Co., Ltd.
Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS
Baxter Healthcare Corporation
Venus BlissMAX
Venus Concept USA, Inc.
BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holde
Becton, Dickinson and Company
Sofsilk Coated Braided Silk Suture
Covidien
Physica LMC Knee System
Limacorporate
S.I.N. Dental Implant System
S.I.N. Implant System Ltda
Pantheris LV Atherectomy Catheter
Avinger, Inc.
Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
Well Lead Medical Co., Ltd.
Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation
Tornier, Inc.
SonoBlock; SonoBlock II
PAJUNK GmbH Medizintechnologie
DeGen Medical Patient Specific Implant (PSI) System
Degen Medical
EXTRON 3; EXTRON 5; EXTRON 7
DRTECH Corporation
Shield System
Radiaction , Ltd.
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
Olympus Medical Systems Corp.
NBR Synthetic Nitrile Examination Gloves
Shandong Langtai International Trade Co., Ltd.
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
Cardinal Health200, LLC
WiEMSpro
Medical Cables S.L.
Catheter Surface Flap Applicator Set (GM11011830)
Varian Medical Systems
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert