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
Air Compression Leg Massager (K-705)
Jiale Health Technology Shenzhen Co., Ltd.
Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2
Shenzhen Kentro Medical Electronics Co., Ltd.
POLARSTEM Calcar Reamer Guide
Smith & Nephew, Inc.
SCORPION Portal Vein Access Set
Argon Medical Devices
Sterile syringes for single use with/without needle
Wepon Medical Technology Co., Ltd.
VOCO Retraction Paste
Voco GmbH
FlightPlan for Embolization
GE Medical Systems SCS
Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B);
Shenzhen AOJ Medical Technology Co., Ltd.
EXPLORER AIR® II
Surgvision GmbH
Porous Biologic Scaffold
Ventris Medical
AutoContour (RADAC V5)
Radformation, Inc.
Invitae Common Hereditary Cancers Panel
Invitae Corporation
Plasma IQ
Neauvia North America, Inc.
ADVIA Centaur Enhanced Liver Fibrosis (ELF)
Siemens Healthcare Diagnostics, Inc.
BD BACTEC FXI Culture System
BD Diagnostic Systems
AxTiHA Stand-Alone ALIF System
Innovasis, Inc.
HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4
Bracco Diagnostics, Inc.
PreXion3D Explorer PRO
Prexion Corporation
Pump In Style® Pro+
Medela, LLC
Metal Bone Screw
Double Medical Technology, Inc.
ds Head 32ch 3.0T
Invivo Corporation (Business Trade Name: Philips)
STARband 3D
Orthomerica Products, Inc.
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
Medtronic, Inc.
MONTAGE Settable, Resorbable Bone Putty
Orthocon, Inc.
U2 Total Knee System-PF+
United Orthopedic Corporation
Allure Hip Stem and Intramedullary Plugs
Waldemar Link GmbH & Co. KG
V-Patch Cardiac Monitor
Shandong Corecare Technology Limited
OcuCool
Recensmedical, Inc.
Point implant system
Pointnix Co., Ltd.
FiberTak® Suture Anchor
Arthrex, Inc.
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