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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

Digital Flat Panel Detector

Ray Imaging Technology (Haining) Limited

DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System

Depuy Ireland UC

Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device

Medtronic, Inc.

T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System

Stryker GmbH

Single Use Bipolar Forceps

Hg Innovations, Ltd.

OsteoCentric ACL Fixation System

OsteoCentric Technologies

CMORE® CT System; CMORE® CT System Navigated Instruments

Icotec AG

Fine Osteotomy™

Bodycad Laboratories, Inc.

Next Generation Access Catheter

Balt USA, LLC

NB 1 SA Implant System

Arum Dentistry Co., Ltd.

SIGMA Spectrum Infusion Pump with Master Drug Library

Baxter Healthcare Corporation

Disposable Endoscope Valve Sets

Sml Med-Tech Solutions Limited

Aspiron S ACP System

U&I Corporation

ASEPT® Glide Peritoneal Drainage System

Pfm Medical, Inc.

M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System

Zsfab

Medical Protective Masks

Qinhuangdao Taizhi Medical Technology Co., Ltd.

BriefCase-Triage

Aidoc Medical , Ltd.

Kneevoice Cartilage Evaluation System (750-3600-001)

Kneevoice, Inc.

LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)

Guangdong Ace-Tec Co., Ltd.

SBC1 Cream

Sioxmed, LLC

Pectus Support Bar System

Biomet Microfixation

Wearable Electric Breast Pump (YM-8803)

Guangdong Youmeng Electrical Technology Co., Ltd.

SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid

Limacorporate

Biobeat Platform, BB-613WP Patch

Biobeat Technologies , Ltd.

Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)

Gigaalaser Company , Ltd.

PGDx elio plasma focus Dx

Personal Genome Diagnostics, Inc.

ProtekDilate Vascular Access Kit

Sorin Group Italia S.R.L.

ASUS Ultrasound Imaging System (LU800 series)

Asustek Computer, Inc.

Easycess Aspiration Pump

Guangzhou Easycess Medical Co.,Ltd

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