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
Materialise TKA Guide System
Materialise NV
NuEra Tight RF Model OptiStream
Bios S.R.L.
AnyPlus Navigated Instruments System
GS Medical Co., Ltd.
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
Olympus Medical Systems Corp.
Sim&Size
Sim&Cure
hygh-tec drainage
Creative Balloons GmbH
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
Scopio Labs , Ltd.
VITROS Immunodiagnostic Products Syphilis Reagent Pack
Ortho Clinical Diagnostics
ROSA® Knee System
Orthosoft D/B/A Zimmer Cas
Injection Needle
Mirco-Tech (Nanjing) Co., Ltd.
Celeris, Disposable Sinus Debrider
Gyrus Acmi, Inc.
Aquilion ONE (TSX-308A/TSX-306A) V2.0
Canon Medical Systems Corporation
ChestView US (1.1)
Gleamer
MOSES Raydar
Boston Scientific Corporation
UltraPrint-Dental Hard Splint UV
Guangzhou Heygears IMC., Inc.
Personal Kinetigraph (PKG) System Gen 2 Plus
Gkc Manufacturing Pty, Ltd.
Denudation Pipettes
Guangzhou Pinzhi Medical Device Co., Ltd.
Sientra, inc. Portfinder
Sientra, Inc.
SmartRead(TM) Medical Device Identifier (4100)
BridgeSource Medical Corporation
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
Medtronic Sofamor Danek USA, Inc.
OviTex PRS (Long Term Resorbable)
Tela Bio
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
Anx Robotica Corporation
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B
Joytech Healthcare Co. , Ltd.
HD 8Ch Wrist Array
Shenzhen RF Tech Co., Ltd.
ARVIS Surgical Navigation System
Kico Knee Innovation Company Pty Limited
Planmed Clarity 2D, Planmed Clarify S
Planmed OY
3.0T AIR 32CH HNA
Ge Healthcare Coils (Usa Instruments, Inc.)
VitalFlow Console
Medtronic, Inc.
Veuron-Brain-pAb2
Heuron Co., Ltd.
Tina-quant Cardiac high sensitivity CRP III
Roche Diagnostics
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