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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

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS

Tuttnauer , Ltd.

MONDRIAN™ Anterior Lumbar Plate System

Ctl Medical Corporation

EDEN Spinal Fixation System

Jmt Co., Ltd.

CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System

CarboFix Orthopedics , Ltd.

CARA System

Cara Medical, Ltd.

Rotatable Connector (5944RL)

Shenzhen Launch Electrical Co., Ltd.

Qlicksmart BladeFlask UNIVERSAL

Qlicksmart Pty , Ltd.

Micro Ace™ Advanced Micro Access System

Merit Medical Systems, Inc.

EMM Ultrasonic Transducer Cover

Exact Medical Manufacturing

SimpleStitch Suturing System

Envision Endoscopy

Bloomi Smooth Water Based Lubricant

The Bloomi Inc..

MasterX 800 Series

Medicatech USA

Evolve System with the T3 Applicator

InMode , Ltd.

Bioptimal Bipolar Pacing Catheter

Bioptimal International Pte. , Ltd.

THE Cover

Purgo Biologics, Inc.

TriMed Threaded Intramedullary Nail System

TriMed, Inc.

Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); P

Nanjing Yinuoji Medical Technology Co., Ltd.

Tenex 2nd Generation System

Trice Medical, Inc.

Topwide Surgical Face Mask

Topwide (Hubei) Medical Products Manufacturer

CONTOUR® NEXT ONE Blood Glucose Monitoring System

Ascensia Diabetes Care

IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17

Shenzhen Century Dongyuan Technology CO , Ltd.

VasQ

Laminate Medical Technologies , Ltd.

Led Mask Platinum Md

Cellreturn Co., Ltd.

MONET Anterior Cervical Plate System

Ctl Medical Corporation

Chemfort® Catheter Adaptor

Simplivia Healthcare , Ltd.

QSCHECK UISACR

Qstag, Inc.

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds

Osartis GmbH

Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)

Guangzhou Red Pine Medical Instrument Co., Ltd.

Videa Caries Assist

Videahealth, Inc.

PosiSep X BAM Hemostat Dressing/Intranasal Splint

Hemostasis, LLC

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