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

QBF 2021-08-12

First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup

Applicant W.H.P.M., Inc.

K-Number K210327

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FYA 2021-08-12

Disposable Surgical Gown

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K-Number K210510

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KWQ 2021-08-12

Prase-C Anterior Cervical Plate System

Applicant Gbs Commonwealth Co., Ltd.

K-Number K211205

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PDU 2021-08-12

Crosser iQ CTO Recanalization System

Applicant C.R. Bard, Inc.

K-Number K203363

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NKG 2021-08-11

Z-LINKPC System

Applicant Zavation Medical Products, LLC

K-Number K211993

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JAK 2021-08-11

uCT ATLAS with uWS-CT-Dual Energy Analysis

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K203448

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NBW 2021-08-11

CONTOUR® NEXT ONE Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care

K-Number K210687

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HGX 2021-08-11

Solo, Swing Maxi

Applicant Medela, LLC

K-Number K210759

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FXX 2021-08-11

Disposable Face Mask

Applicant Chaozhou Cecilia Technology Co., Ltd.

K-Number K203152

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QGN 2021-08-11

Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit

Applicant Cd Diagnostics, Inc.

K-Number K212204

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HSN 2021-08-11

QUANTUM® Patient Specific Instrumentation (PSI) System

Applicant In2bones Sas

K-Number K211883

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FLL 2021-08-11

Sensatronic Reusable Temperature Probes

Applicant Sensatronic GmbH

K-Number K203643

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