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

FYA 2018-07-13

Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)

Applicant Gmax Industries, Inc.

K-Number K172987

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PDJ 2018-07-13

Dimension Hemoglobin A1c Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K173909

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PLR 2018-07-13

Normandy VBR System

Applicant Zavation Medical Products, LLC

K-Number K180673

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BZG 2018-07-13

Pulmonx Chartis Tablet Console

Applicant Pulmonx Corporation

K-Number K180011

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EZL 2018-07-13

Yikang Latex Foley Catheter

Applicant Jiangxi Yikang Medical Instrument Group Co., Ltd.

K-Number K173340

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KWQ 2018-07-13

Kestrel™ Buttress Plate System

Applicant Innovasis, Inc.

K-Number K181063

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GEI 2018-07-13

PINXEL-RF system

Applicant Rohrer Aesthetics, LLC

K-Number K180654

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NKB 2018-07-13

Viking Lumbar Polyaxial Screw System

Applicant Presidio Surgical

K-Number K180655

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DBM 2018-07-13

EliA M2 Immunoassay

Applicant Phadia AB

K-Number K181556

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INI 2018-07-13

Solax Electric Scooter, Models: S302121, S302131, S302141, S302151

Applicant Dongguan Prestige Sporting Goods., Ltd.

K-Number K172440

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KGO 2018-07-13

Sterile Latex Surgical Gloves, Powder Free

Applicant Sanrea Healthcare Products Pvt, Ltd.

K-Number K171550

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HWC 2018-07-13

Injection Screw

Applicant Biedermann Medtech, Inc.

K-Number K173556

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