Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

DZI 2018-01-12

PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE

Applicant Mectron S.P.A.

K-Number K171958

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HSB 2018-01-12

T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System

Applicant Stryker Trauma GmbH

K-Number K172774

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BSZ 2018-01-12

A7 Anesthesia System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K171292

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DQX 2018-01-12

HI-TORQUE TurnTrac Guide Wire Family

Applicant Abbott Vascular

K-Number K173795

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HWC 2018-01-12

HBS2 Headless Bone Screw

Applicant Stuckenbrock Medizintechnik GmbH

K-Number K171628

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NKB 2018-01-12

Wiltrom Spinal Fixation System

Applicant Wiltrom Corporation Limited

K-Number K172548

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DQY 2018-01-12

Microcatheter

Applicant Surmodics,Inc.

K-Number K173560

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MQE 2018-01-12

Single Lumen Ovum Aspiration Needles

Applicant Willian A. Cook Australia Pty, Ltd.

K-Number K171625

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IYN 2018-01-12

6440 Ultrasound System

Applicant Esaote, S.p.A.

K-Number K173291

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MUJ 2018-01-12

syngo.via RT Image Suite

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173635

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BTR 2018-01-12

IRRIS (Infra-Red-Red Intubation System)

Applicant A.R Guide IN Medical , Ltd.

K-Number K171411

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KPR 2018-01-12

GU60A & GU60A-65

Applicant Samsung Electronics Co., Ltd.

K-Number K173828

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