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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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