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

PKR 2021-09-10

gammaCore Sapphire

Applicant Electrocore, Inc.

K-Number K211856

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IYN 2021-09-10

Versana Premier

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K210438

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FMF 2021-09-10

Sterile syringe for single use with/without needle

Applicant Zhejiang Kangkang Medical-Devices Co., Ltd.

K-Number K210227

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DRF 2021-09-10

Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter

Applicant Boston Scientific Corporation

K-Number K211375

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LLZ 2021-09-10

Kinepict Medical Imaging Tool 4.0

Applicant Kinepict Health, Ltd.

K-Number K202056

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QIH 2021-09-10

ClariSIGMAM

Applicant Claripi, Inc.

K-Number K203785

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NHA 2021-09-10

s-Clean Pre-Milled Abutment Mini

Applicant Dentis Co., Ltd.

K-Number K210410

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FXX 2021-09-10

Surgical Mask

Applicant Remade USA, LLC

K-Number K212451

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GXH 2021-09-10

Iovera System

Applicant Pacira Pharmaceuticals, Inc.

K-Number K211334

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JAK 2021-09-10

Aquilion Exceed LB

Applicant Canon Medical Systems Corporation

K-Number K211828

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MAX 2021-09-10

Explorer TO System

Applicant SeaSpine Orthopedics Corporation

K-Number K212540

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MSX 2021-09-10

AlertWatch:AC

Applicant Alertwatch, Inc.

K-Number K210160

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