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

HWC 2021-10-05

ChM 4.5mm Cortical screws

Applicant Chm Sp. Z O.O.

K-Number K210490

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HRS 2021-10-05

SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System

Applicant Bonebridge AG

K-Number K203002

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QBC 2021-10-05

Cala Trio

Applicant Cala Health, Inc.

K-Number K203288

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DPS 2021-10-05

Scan Monitor

Applicant Withings SA

K-Number K201456

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LZA 2021-10-05

Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs

Applicant Jiangsu Yanfang Medical Technology Co., Ltd.

K-Number K212036

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MWI 2021-10-05

Vital Signs Monitors

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K211475

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LLZ 2021-10-05

NAVIPLAN - CT Planning Software for Total Hip Replacement

Applicant Naviswiss AG

K-Number K211429

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FMF 2021-10-05

Sterile hypodermic syringes for single use

Applicant Jiangsu Kangyou Medical Instrument Co., Ltd.

K-Number K211728

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LNH 2021-10-05

RTHawk, HeartVista Cardiac Package

Applicant Heartvista, Inc.

K-Number K212233

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FXX 2021-10-04

Private Stock Labs Surgical Face Mask

Applicant J.K. Private Stock, Inc.

K-Number K211425

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LLZ 2021-10-04

EzDent-i/ E2/ Prora View/ Smart M Viewer

Applicant Ewoosoft Co., Ltd.

K-Number K211795

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FXX 2021-10-04

Surgical Face Mask

Applicant Hubei Yi-Ya Protective Products Co., Ltd.

K-Number K211899

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