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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

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

Haemonetics Corporation

Emerge Monorail PTCA Dilatation Catheter

Boston Scientific

LightStim for Wrinkles (1984); LightStim for Acne (2038)

Led Intellectual Properties, LLC

Dukal SMS Sterilization Wrap

Dukal, LLC

A.B. Dental Devices Dental Implants System

A.B. Dental Device , Ltd.

AirLife DuoTherm™ Humidification System

Vyaire Medical, Inc.

FirstFit Surgical Kit

Freudenberg Medical, LLC

MitraPatch Mitral Valve Repair System

Chawla Heart Technologies, LLC

uAngio AVIVA CX

Shanghai United Imaging Healthcare Co., Ltd.

SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reli

Globus Medical, Inc.

Disposable Stone Extraction Basket

Zhejiang Soudon Medical Technology Co., Ltd.

Zionic Pro Max (Radiofrequency)

Termosalud S.L.

Introcan Safety 3 Closed IV Catheter

B.Braun Medical, Inc.

Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)

Agada Medical, Ltd.

QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)

Fysicon BV

Procise ADL

Procisedx, Inc.

YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff

Nihon Kohden Corporation

IntelliSep Test

Cytovale, Inc.

Apollo ESG NXT System, Apollo REVISE NXT System

Apollo Endosurgery, Inc.

LTV2 Series Ventilators

Vyaire Medical, Inc.

Molecular Transport Media - MTM

Alb Luz

Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)

Sichuan Qianii-Beoka Medical Technoiogy Lnc.

Vathin Video Bronchoscope System

Hunan Vathin Medical Instrument Co., Ltd.

Compression Therapy Device (LGT-2202DVT)

Guangzhou Longest Medical Technology Co., Ltd.

Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2

Ambu A/S

RZ Resectoscope System

Rz Medizintechnik GmbH

BioHorizons CEREC Compatible Ti-Bases

BioHorizons Implant Systems, Inc.

EffortMed Spinal Fixation System

Effortmed, LLC

Access EPO

Beckman Coulter, Inc.

CO2 Laser Therapy System (K106)

Hebei Keylaser Sci-Tech Co.,Ltd

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