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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

Vektor Computational ECG Mapping System (vMap®)

Vektor Medical, Inc.

ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCu

Medtronic Xomed, Inc.

Stethophone

Sparrow Acoustics, Inc.

ATM Glove

Phu Duc Huy Production Trading Services Corporation

Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

Olympus Medical Systems Corporation

ArcSP Suprapubic Sling System

Urocure, LLC

Dynamic TiBase

Talladium España, SL

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy

Mercator Medical (Thailand), Ltd.

Swoop® Portable MR Imaging® System

Hyperfine, Inc.

Powder Free Nitrile Patient Examination Gloves, Blue Color

Shandong Jieshi Medical Products Co., Ltd.

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)

Alliage S/A Industrias Médico Odontológica

Aerin Console

Aerin Medical, Inc.

Prostate Core

Lucida Medical, Ltd.

Pixyl.Neuro

Pixyl SA

Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002A

Shenzhen Fansizhe Science and Technology Co., Ltd.

Optimotion Implants Porous Metal-Backed Patella

Optimotion Implants, LLC

Dr. Yglo Skin Tag Remover

Theotclab Healthcare B.V.

DS Core CBCT Anatomy

Dentsply Sirona

VitroPRO

CIVCO Medical Instruments Co., Inc.

FIX-L PEEK PLIF and T-PLIF System

Jeil Medical Corporation

ProLift Micro Expandable Spacer System

Life Spine, Inc.

OK Handpiece

Jaintek Co.,Ltd

BA-004CC

Fujifilm Corporation

F&P Evora Full Face Mask

Fisher & Paykel Healthcare, Ltd.

Stryker Resorbable Fixation System

Stryker Leibinger Micro Implants

Syngo Carbon Enterprise Access (VA40A)

Siemens Healthcare GmbH

Oxygen Concentrator

Foshan Mic Medical Technology Co., Ltd.

Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim

Riverstone Resources Sdn Bhd

Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair R

Guangzhou Chuang Zao Mei Technology Co., Ltd.

TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System

Life Spine, Inc.

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