Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

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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ELC 2021-02-05

GentleWave X

Applicant Sonendo, Inc.

K-Number K203302

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OWB 2021-02-05

Cios Spin

Applicant Siemens Medical Systems USA, Inc.

K-Number K210054

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JDI 2021-02-05

ELEOS™ Limb Salvage System

Applicant Onkos Surgical

K-Number K203588

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HTY 2021-02-05

LimaCorporate Kirschner Wire

Applicant Lima Corporate S.P.A.

K-Number K203475

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MAI 2021-02-05

The Citrefix Knotless Suture Anchor

Applicant Acuitive Technologies, Inc.

K-Number K203334

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KNS 2021-02-05

Sphincterotome

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K201121

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