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

POS 2021-02-06

SPEAC System

Applicant Brain Sentinel, Inc.

K-Number K200276

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CBK 2021-02-05

HAMILTON-C3

Applicant Hamilton Medical AG

K-Number K201306

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QIH 2021-02-05

LVivo Software Application

Applicant Dia Imaging Analysis, Ltd.

K-Number K210053

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MUH 2021-02-05

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)

Applicant De Götzen S.R.L.

K-Number K203374

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DSH 2021-02-05

Carnation Ambulatory Monitor (CAM)

Applicant Bardy Diagnostics, Inc.

K-Number K210036

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PHX 2021-02-05

LINK Embrace Shoulder System - Reverse Configuration

Applicant Waldemar Link GmbH & Co. KG

K-Number K200368

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FXX 2021-02-05

Freudenberg Surgical Mask

Applicant Freudenberg Performance Materials LP

K-Number K210063

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NKG 2021-02-05

SYMPHONY OCT System

Applicant Medos International SARL

K-Number K203319

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OWB 2021-02-05

Cios Alpha

Applicant Siemens Medical Solutions USA, Inc.

K-Number K210055

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FXX 2021-02-05

Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons

Applicant Dukal Corporation

K-Number K201421

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LLZ 2021-02-05

Bonelogic

Applicant Disior, Ltd.

K-Number K203290

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GDW 2021-02-05

Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload

Applicant M/s. Meril Endo Surgery Private Limited.

K-Number K200320

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