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
Avanti Orthopaedics Ulnar Shortening System
Avanti Orthopaedics, Inc.
TrueBeam, TrueBeam STx, Edge, VitalBeam
Varian Medical Systems, Inc.
Biological Feedback and Stimulation System
Medlander Medical Technology, Inc.
ProSeal Vented Universal Vial Adaptor
Epic Medical Pte. , Ltd.
InnoVoyce Laser Fiber
Innovoyce, LLC
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Canon Medical Systems Corporation
RADIFOCUS Torque Device
Terumo Medical Products (Hangzhou) Co., Ltd.
The InMode System with the Morpheus8 Applicators
InMode , Ltd.
BriefCase-Triage
Aidoc Medical , Ltd.
Orchid Safety Release Valve
Linear Health Sciences, LLC
BD Alaris System with Guardrails Suite MX v12.1.2
Carefusion 303, Inc.
EnSite X EP System
ABBOTT MEDICAL
Besmed Bacterial Filter and HMEF
Besmed Health Business Corp
MyKnee R Pin Positioners
Medacta International S.A.
SperSort Sperm Sorting Chip (IPG02)
Ipreg Incorporation
Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)
Cnc Technologies
Digital Intraoral X-ray Imaging System
Iray Technology Taicang , Ltd.
Salix Coronary Plaque (V1.0.0)
Artrya Limited
MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System
C2dx, Inc.
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
Medtronic Vascular
ENTire IRE System
Entire Medical , Ltd.
Healgen URS Test Strips
Healgen Scientific,, LLC
Brainomix 360 Triage ICH
Brainomix Limited
NX01 (NX01)
Naox Technologies Sas
QuikPass Catheter
Traverse Vascular, Inc.
Iconix Speed Anchor; Iconix Speed HA+ Anchor
Riverpoint Medical
Device 300397 Putty
Geistlich Pharma AG
Blood Pressure Monitor
Guangdong Transtek Medical Electronics Co., Ltd.
ENDOGATOR Hybrid Irrigation Tubing
Medivators
CREOKORREKT Aligners
Creodent Prosthetics, Ltd.
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