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

LZA 2021-07-12

Nitrile Patient Examination Glove

Applicant Jiangxi Zhonghong Pulin Medical Products Co., Ltd.

K-Number K210723

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LZA 2021-07-10

Medical Nitrile Examination Gloves (Power free, Blue)

Applicant Jiangxi Hongda Medical Equipment Group , Ltd.

K-Number K210578

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MQB 2021-07-09

PRIMO S

Applicant A.T.S. Applicazione Tecnologie Speciali S.R.L.

K-Number K211542

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LON 2021-07-09

VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)

Applicant bioMerieux, Inc.

K-Number K201675

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LOD 2021-07-09

PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro

Applicant Heraeus Medical GmbH

K-Number K210607

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LOX 2021-07-09

Tamarin Blue PTCA RX Dilatation Catheter

Applicant Natec Medical , Ltd.

K-Number K210012

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EOQ 2021-07-09

Monarch Platform

Applicant Auris Health, Inc.

K-Number K211493

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LYZ 2021-07-09

Medical PVC Examination Gloves

Applicant Jiangxi Hongda Medical Equipment Group , Ltd.

K-Number K210821

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NUC 2021-07-09

Grosz Play Feel

Applicant Rb Health (Us), LLC

K-Number K211088

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GEI 2021-07-09

BTL-899 FP

Applicant BTL Industries, Inc.

K-Number K211107

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QAI 2021-07-09

Cytrellis Dermal Micro-Coring System

Applicant Cytrellis Biosystems, Inc.

K-Number K202517

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IYN 2021-07-09

HM70 EVO Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K210713

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