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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

VariTrax Sternal CircumFixation System

Circumfix Solutions, Inc.

Cold Sore Device (QPZ-03)

Shenzhen Nuon Medical Equipment Co., Ltd.

Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introd

William Cook Europe Aps

Jazz Classic

Jazz Imaging

SpeedCath Compact Male

Coloplast

Curiteva Porous PEEK Standalone ALIF System

Curiteva, Inc.

LiverMultiScan v5 (LMSv5)

Perspectum

Medical Face Masks, Model Name:MY020003

Huizhou Jie Bai Purification Co., Ltd.

Newclip Patient-matched instrumentation non sterile PSI

Newclip Technics

X-PAC® N-GAGE™ Lumbar Plate System

Expanding Innovations, Inc.

TearRepair Liquid Skin Protectant

Optmed, Inc.

Zilia Ocular FC (ZIL-10002)

Zilia, Inc.

Cobra Catheter System

Endovascular Engineering

Careflux H60;Careflux H70;Careflux V500

Fresenius Medical Care Renal Therapies Group, LLC

CORIS System

Nanosonics Limited

AMC Health CareConsole

Amc Health

Sterisystem Dry-Base Instrument Tray

O&M Halyard, Inc.

Sway System Sports Plus

Sway Medical, Inc.

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo

Ellex Medical Pty, Ltd.

PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)

Pureway Compliance, Inc.

Biocore9 Acetabular Cup System

Biocore9, LLC

Disposable Warming Blanket

Hangzhou Tappa Medical Technology Co., Ltd.

Lavieen

Wontech Co., Ltd.

SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Steril

Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

Invictus® Spinal Fixation System

Alphatec Spine, Inc.

CIRRUS™ HD-OCT Model 6000

Carl Zeiss Meditec, Inc.

Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System

Immuno Concepts, N.A. , Ltd.

CERAMENT G

Bonesupport AB

allay Nerve Cap

Tulavi Therapeutics

MAGNETOM Vida with syngo MR XA50A

Siemens Medical Solutions USA, Inc.

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