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
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Softw
Brainlab AG
Instant-View® hCG Combo II Cassette Test
Alfa Scientific Designs, Inc.
BriefCase
Aidoc Medical , Ltd.
Shield System
Radiaction , Ltd.
BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube
Becton, Dickinson and Company
IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)
Foshan Jindi Electric Appliance Co., Ltd.
Suture Button Repair System
Skeletal Dynamics, Inc.
Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)
Augment Intelligent Medical System (China) Co., Ltd.
Frontier X Plus
Fourth Frontier Technologies Pvt, Ltd.
Dental Computed Tomography X-ray System
Fussen Technology Co., Ltd.
Multistage Balloon Dilatation Catheter
Dongguan TT Medical, Inc.
VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits
AngioDynamics, Inc.
EcoFit® short stem cementless cpTi
Implantcast GmbH
Access Intrinsic Factor Ab
Beckman Coulter, Inc.
HDF Assist Mudule, HDF Infusion Set and Substitution Filter
Nephros
Copra Smile, Copra Supreme Hyperion
Whitepeaks Dental Solutions GmbH
Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)
Soul Mobility
CPL Surgical Face Mask
Control Print Limited
Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162,
Asistan Medikal
CiRX Single use electrosurgical pencil with non-coated and coated electrode
Ningbo Shun YE Medical Company, Ltd.
Ultra-Fast Vitri; Ultra-Fast Warm
Kitazato Corporation
SMARTVERTIGO Vestibular Assessment System
VertigoDx, Inc.
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
Orthocon, Inc.
Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3%
Theodent, LLC
BENCOX Mirabo Z Cup Cortinium
Corentec Co., Ltd.
Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml
Cardinal Health, LLC
ICON 35; ICON 45; ICON 60; ICON 30FAF
Rehasense USA, Inc.
Root Apex Locator
Foshan Coxo Medical Instrument Co., Ltd.
GBrain MRI
Galileo Cds, Inc.
Biolinq Shine Autonomous Time-in-Range Microsensor
Biolinq Incorporated
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