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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

ARIES Anterior Cervical Plate Systems

ZheJiang Decans Medical Devices Co., Ltd.

Remanufactured EndoWrist Long Tip Forceps (420048)

Rebotix

BNLE Hydrophilic Jacketed Peripheral Guidewire

Biomerics Nle

XC11 ICE System, USA

Yorlabs, Inc.

Biotres

Biotricity

BTI Interna Dental Implant System UnicCa - Prosthetic Components

B.T.I. Biotechnology Institute, Sl.

C350/C350G LCD Monitor; M550/M550G LCD Monitor

Nanjing Jusha Display Technology Co., Ltd.

Scan Monitor

Withings SA

HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R

Samsung Medison Co., Ltd.

BriefCase-Triage

Aidoc Medical , Ltd.

Catalyft LS Expandable Interbody System

Medtronic Sofamor Danek USA, Inc.

IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002

Dongguan Lide Electric Appliance Co., Ltd.

Ureteral Access Sheath

Seplou (Zhuhai) Co., Ltd.

Oryx Cloud Imaging

Oryx Dental Software, Inc.

Passio Pump Drainage System

Bearpac Medical

Indigo® Aspiration System – Aspiration Catheter 6X

Penumbra, Inc.

ArtiFascia

Nurami Medical , Ltd.

WSA Self-Fitting Hearing Aid Gen 2

Wsaud A/S

DCX Disposable Cassette (DCX)

Institut Geroges Lopez

CORGRIP* SR NG/NI Tube Retention System

Avanos Medical, Inc.

CARESCAPE R860

Datex-Ohmeda, Inc.

Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

Beckman Coulter, Inc.

CoreLink Navigation Instruments

Corelink, LLC

PreXion3D Expedition

Prexion Corporation

MAGNETOM Avanto Fit

Siemens Medical Solutions USA, Inc.

R2P Navicross

Terumo Medical Corporation

RIGHTEST Blood Glucose Monitoring System Max Tel

Bionime Corporation

Disposable Surgical Gown

Shandong Zhushi Pharmaceutical Group Co., Ltd.

RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)

Li Medical Corporation , Ltd.

AquaA

Fresenius Medical Care Rental Therapies Group, LLC

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