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

NHA 2019-06-20

Panthera Dental Milled Bars

Applicant Panthera Dental, Inc.

K-Number K183580

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NKB 2019-06-20

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0

Applicant Icotec AG

K-Number K190545

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PMN 2019-06-20

Cepheid Xpert MRSA NxG Control Panel

Applicant Microbiologics, Inc.

K-Number K191172

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LQP 2019-06-20

Campylobacter Chek

Applicant Techlab, Inc.

K-Number K191442

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GXP 2019-06-20

DB-CMF

Applicant Dimensional Bioceramics, LLC

K-Number K182742

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PBX 2019-06-20

EmBody System

Applicant Inmode MD , Ltd.

K-Number K183450

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GEI 2019-06-20

Soniquence Bipolar Electrodes

Applicant Soniquence, LLC

K-Number K190336

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LYZ 2019-06-20

Powder-Free Clear Vinyl Patient Examination Gloves

Applicant Anhui Intco Medical Products Co., Ltd.

K-Number K190095

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JWH 2019-06-20

Renovis A200 PS Knee System as part of the Renovis A200 Knee System

Applicant Renovis Surgical Technologies

K-Number K190122

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NKB 2019-06-19

The JASPER Spinal Fixation System II

Applicant Gbs Commonwealth Co., Ltd.

K-Number K190762

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PAY 2019-06-19

STOP U (Packed Black USA), STOP U (Packed White USA)

Applicant Pollogen, Ltd.

K-Number K182774

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DKZ 2019-06-19

Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro

Applicant Quidel Cardiovascular, Inc.

K-Number K182719

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