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

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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CAF 2019-06-19

Hailie Sensor

Applicant Adherium (Nz), Ltd.

K-Number K182638

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PCH 2019-06-19

EntericBio Dx Assay

Applicant Serosep , Ltd.

K-Number K182703

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NXC 2019-06-19

Bioliner

Applicant Five Star Orthodontic Lab & Supply

K-Number K182658

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KPR 2019-06-19

Multix Fusion Max

Applicant Siemens Medical Solutions USA, Inc.

K-Number K191418

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