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

MQV 2021-10-08

ABCcolla Bone Matrix

Applicant Acro Biomedical Co., Ltd.

K-Number K212156

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FLL 2021-10-08

Infrared Thermometer (Model K9)

Applicant Kangzhan Communication Electronics Co., Ltd.

K-Number K203497

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ESW 2021-10-08

Esophageal TTS Stent

Applicant Taewoong Medical Co., Ltd.

K-Number K211706

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DZL 2021-10-08

The Micro Screw System, Micro Screw System Basic

Applicant Hager& Meisinger GmbH

K-Number K201210

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GWM 2021-10-08

B4C System

Applicant Braincare Desenvolvimento E Inovacao Tecnologica S.A.

K-Number K201989

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FMF 2021-10-07

Sterile syringes for single use with/without needle

Applicant Azur Medical Company, Inc.

K-Number K211211

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DPW 2021-10-07

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger

Applicant Remington Medical, Inc.

K-Number K212065

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MHX 2021-10-07

IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K210906

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LNH 2021-10-07

OASIS MRI System

Applicant Hitachi Healthcare Americas

K-Number K211406

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FYA 2021-10-07

Surgical Gown

Applicant Wujiang Tutaike Textiles & Finishing Co., Ltd.

K-Number K211077

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KGN 2021-10-07

NeoMatriX Wound Matrix

Applicant Nextgen Biologics, Inc.

K-Number K210024

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OHT 2021-10-07

Superior Hair Remover

Applicant Guangzhou Haoxingwan Technology Co., Ltd.

K-Number K210376

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