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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

uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse P

Wuhan United Imaging Healthcare Co.,Ltd

Alpha Dent Implants Dental Implants System

Alpha Dent Implants GmbH

SAGICO Spinal System

Sagico VA USA, LLC

Advanced Tissue Resection Device

Micro-Tech (Nanjing) Co., Ltd.

OIC Variable Angle Small Fragment Locking Plate System

Orthopaedic Implant Company

DuraGraft Vascular Conduit Solution

Marizyme

VXvue

Vieworks Co., Ltd.

Saans (F4-01-00-000-000)

Innaccel Technologies Private Limited

Current Health System

Current Health , Ltd.

RemeOs™ Screw LAG Solid

Bioretec, Ltd.

Avatar Medical Software V1

Avatar Medical

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT

Healgen Scientific,, LLC

VariTrax Sternal CircumFixation System

Circumfix Solutions, Inc.

uMI Panvivo

Shanghai United Imaging Healthcare Co., Ltd.

CO2 Laser Therapy System (Model: LFS-D9U)

Sanhe Lefis Electronics Co., Ltd.

Picosecond Laser System (Model PS10-A and PS10-B)

Beijing Adss Development Co., Ltd.

CoreLink Navigation Instruments

Corelink, LLC

Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (R

Centerline Biomedical, Inc.

APOLLO ADVANTAGE Nitrile Examination Gloves

Dell Corning Corporation

Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive

Ormco Corporation

LC ChromeFlow

S&C Polymer Silicon- Und Composite Spezialitaten GmbH

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application

Hearx SA (Pty) , Ltd.

JADE PLUS PTA Balloon Dilatation Catheter

OrbusNeich Medical (Shenzhen) Co., Ltd.

JAZZ Solo sensor

Jazz Imaging, LLC Dba Jazz Imaging

Disposable Dual Action Tissue Clip

Micro-Tech (Nanjing) Co., Ltd.

SpineAR SNAP (SyncAR Spine)

Surgical Theater, Inc.

NaviCam ProScan

Ankon Technologies Co., Ltd.

Portare System (FA-001)

Grumpy Innovation, Inc.

Ion-L

SurGenTec, LLC

Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-

Nanjing Devin Medical Technology Co., Ltd.

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