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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

Ultra RapidWarm™ Blast

Vitrolife Sweden AB

Capsule Vitals Plus Patient Monitoring System

Capsule Technologie Sas

Portable Scalp Cooling System

Cooler Heads Care, Inc.

X-Guide® Surgical Navigation System

X-Nav Technologies, LLC

SafeR Syringe and SafeR Sting

Roncadelle Operations Srl

Pulse Oximeter

Beijing Choice Electronic Technology Co., Ltd.

Kurin Blood Culture Collection Set with Kurin Lock Technology

Kurin, Inc.

Grappler Interference Screw System

Paragon 28, Inc.

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)

Hindernis DE Mexico, S.A.P.I. DE C.V.

Articulator Arthroscopic Bur

Joint Preservation Innovations, LLC

GPA (hexafocon A) Rigid Gas Permeable Contact Lenses

Zhuhai Fitlens Medical Technology Co., Ltd.

BriefCase

Aidoc Medical , Ltd.

Power wheelchair

Zhejiang Zhonglei Medical Technology Co. , Ltd.

OSSIOfiber® Interference Screw

OSSIO , Ltd.

Aptiva CTD Essential Reagent

Inova Diagnostics, Inc.

NS-HGlio

Neosoma, Inc.

AnemoCheck Home

Sanguina, Inc.

Glidewell Appliance Resin, Hard/Soft

Prismatik Dentalcraft, Inc.

Toro-L Interbody Fusion System

Integrity Implants, Inc.

AdVance™ XP Male Sling System (720163-03)

Boston Scientific Corporation

syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

inspired™ VHB20 Heated Humidifier

Vincent Healthcare Products Limited

PainShield MD PLUS

Nanovibronix, Inc.

LungQ v3.0.0

Thirona BV

Quantra QStat Cartridge

Hemosonics, LLC

BASE290 LED Curing Light

Handpiece Headquarters

Disposable Brain Biopsy Needle 2.0

PAJUNK GmbH Medizintechnologie

Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code AC

Trax Surgical

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)

Taiwan Aulisa Medical Devices Technologies, Inc.

Steriking® LT-Blueline Pouches with Tyvek®

Wipak OY

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