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
ErgoSteel (ES0001/696)
Strongback Mobility AG C/O Blueaudit GmbH
Ziehm Solo FD
Ziehm Imaging GmbH
CREED Cannulated Screws
Glw, Inc.
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
Boston Scientific Corporation -
InThrill Thrombectomy System
Inari Medical, Inc.
XeliteMed VertehighFix High Viscosity Spinal Bone Cement
Xelite Biomed , Ltd.
DTX Studio Assist
Nobel Biocare C/O Medicim NV
Elos Accurate Hybrid Base
Elos Medtech Pinol A/S
EyeBOX EBX-4.1
Oculogica, Inc.
SurfRider 13 Microcatheter
Kaneka Americas Holding, Inc.
Radiance V5
Gmv Soluciones Globales Internet S.A.U.
Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters Single-use Bronchoscope/Insigh
Shenzhen Insighters Medical Technology Co., Ltd.
SiteRite 9 Ultrasound System
Bard Access Systems, Inc. (C.R. Bard, Inc.)
Zeta Cranial Navigation System
Zeta Surgical
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
Xingyu Medical Tech Co., Ltd.
The Circadia C200 System
Circadia Technologies, Ltd.
Medical Image Post-processing Software (uOmnispace.CT)
Shanghai United Imaging Healthcare Co., Ltd.
BTL-995-rTMS
BTL Industries, Inc.
SM-V
Sedecal., Sa.
Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
Stryker GmbH
Savvy Surgical Mask - Level 3
Alg Health, LLC
Imagine® Enterprise Suite
Softlink International Private Limited
Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
Canon Medical Systems Corporation
Hintermann Series H2 Total Ankle System
Vilex, LLC
Baby Gorilla®/Gorilla® Plating System
Paragon 28, Inc.
Galen ES Cooperative Surgical Assistant Platform, Galen ES
Galen Robotics
SOTA Cloud Smart Sensor (1.5)
Sota Cloud Corp.
TearCare MGX System
Sight Sciences, Inc.
ARIX Ankle System
Jeil Medical Corporation
Kentrospine Viktr-MIS® Pedicle screw system
Rivarp Medical Pvt., Ltd.
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