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
Light-Guide Cables
Olympus Winter & Ibe GmbH
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve T
Spectrum Vascular
Tyto Insights for Eardrum Bulging Detection
Tyto Care , Ltd.
Disposable Injection Needles
Ningbo Xinwell Medical Technology Co., Ltd.
High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straig
Foshan Soco Precision Instrument Co., Ltd.
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
Haemonetics Corporation
HYDRASHIFT 2/4 isatuximab
Sebia
Maxiocel Chitosan Wound Dressing
Advamedica, Inc.
Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments
Southern Implants (Pty), Ltd.
CT Rembra RT; CT Areta RT; CT Rembra
Philips Healthcare (Suzhou) Co., Ltd.
CoaguChek XS Plus System
Roche Diagnostics
Mandibular Advancement Device L07
Dcstar, Inc.
Puracyn® Plus Antimicrobial Irrigation Solution
Innovacyn, Inc.
ZIIP+ Device
Ziip, Inc.
Ziehm Solo FD
Ziehm Imaging GmbH
EUROPA Posterior Cervical Fusion System
MiRus, LLC
MDHearingAid app, MDHearingAid Smart hearing aids
Mdhearingaid
Excipio SV Aspiration Catheter and Tubing
Contego Medical, Inc.
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)
Hunan Haipuming Technology Co., Ltd.
VisiRad XR
Imidex, Inc.
Alma Harmony
Alma Lasers, Inc.
CryoFreeze Wart and Skin Tag Remover
Cryosurgery, Inc.
Rayvolve
Azmed Sas
Harmony Latex Dam, Harmony Non-Latex Dam
Pamco Distributing, Inc.
DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet ME
Htl-Strefa S.A
NuCath Wedge Pressure Catheter
Pfm Medical, Inc.
CONNEQT PULSE
Atcor Medical
AAMI4 Isolation Gown
Hubei Xinxin Non-Woven Co., Ltd.
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
Shenzhen Ionka Medical Technology Co., Ltd.
AIAS Cephalon
Metamorphosis GmbH
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