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

MEG 2020-04-10

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use

Applicant Gemtier Medical (Shanghai), Inc.

K-Number K192679

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IYN 2020-04-10

ACUSON Freestyle Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K200644

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PLC 2020-04-10

Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac

Applicant Residential Home Sleep Services

K-Number K190353

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QAI 2020-04-10

SkinStylus SteriLock MicroSystem

Applicant Esthetic Education, LLC

K-Number K200044

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OLO 2020-04-10

OrthAlign Plus System

Applicant Orthalign, Inc.

K-Number K200642

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LLZ 2020-04-10

VARO Plan

Applicant 3D Industrial Imaging Co., Ltd.

K-Number K200078

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LZO 2020-04-10

Zimmer Hip Joint Replacement

Applicant Zimmer GmbH

K-Number K200112

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LNH 2020-04-10

SIGNA Premier

Applicant Ge Healthcare (Ge Medical Systems, LLC)

K-Number K193282

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MQB 2020-04-10

DR-ID 1200SDK System

Applicant Fujifilm Corporation

K-Number K200668

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KGO 2020-04-10

Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro

Applicant Molnlycke Health Care Us, LLC

K-Number K193573

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LNH 2020-04-10

Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems

Applicant Philips Medical Systems Nederland B.V.

K-Number K193215

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LZA 2020-04-10

KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid

Applicant Kimberly-Clark Corporation

K-Number K200072

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