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

HSB 2021-05-26

Fassier-Duval Telescopic IM System

Applicant Pega Medical, Inc.

K-Number K211292

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LYZ 2021-05-26

Disposable Synthetic Examination Gloves

Applicant Shandong Shengshixincheng Medical Science & Technology Co.,

K-Number K210520

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FDS 2021-05-25

Pathfinder Endoscope Cap

Applicant Neptune Medical, Inc.

K-Number K210915

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KTT 2021-05-25

MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

Applicant Synthes (USA) Products, LLC

K-Number K211313

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QAI 2021-05-25

MicroPen EVO

Applicant Eclipse Medcorp, LLC

K-Number K203144

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DSY 2021-05-25

HeRO Graft, HeRO Adapter

Applicant Merit Medical Systems, Inc.

K-Number K203724

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MXD 2021-05-25

LUX-Dx Insertable Cardiac Monitor

Applicant Boston Scientific Corporation

K-Number K210608

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FXX 2021-05-25

AirMax Procedure Mask

Applicant Premiumestore, LLC

K-Number K211275

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IRP 2021-05-25

Air Relax Plus Model AR-3.0

Applicant Diode Art Engineering Doing Business AS Air Relax

K-Number K211460

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EBF 2021-05-25

E-Dent 1000

Applicant Envisiontec GmbH

K-Number K210977

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KLE 2021-05-25

Tokuyama Universal Bond II

Applicant Tokuyama Dental Corporation

K-Number K203760

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MAX 2021-05-24

Catalyft PL Expandable Interbody System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K210425

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