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

FHN 2022-06-06

Multi-Band Ligator

Applicant Beijing Zksk Technology Co., Ltd.

K-Number K213223

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PBX 2022-06-06

Diacare 7000

Applicant Globus Sport and Health Technologies, LLC

K-Number K211207

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LZA 2022-06-06

Powder Free Nitrile Gloves

Applicant St Future International Limited

K-Number K213448

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FXX 2022-06-06

Surgical Face Mask (HNFM0304)

Applicant Shanghai Hua EN Industrial Co, Ltd.

K-Number K221222

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FPA 2022-06-05

Q2 Blood Administration Sets

Applicant Quest Medical, Inc.

K-Number K213846

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LLZ 2022-06-03

3D Anatomic Models

Applicant Ricoh USA, Inc.

K-Number K220205

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HAE 2022-06-03

KLS Martin Neuro Rongeurs

Applicant KLS-Martin L.P.

K-Number K210741

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IYE 2022-06-03

TrueBeam, TrueBeam STx, Edge, VitalBeam

Applicant Varian Medical Systems, Inc.

K-Number K213977

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LZO 2022-06-03

BiMobile Instruments (for BiMobile Dual Mobility System)

Applicant Waldemar Link GmbH & Co. KG

K-Number K211567

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QEP 2022-06-03

Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris

Applicant Hologic, Inc.

K-Number K220321

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FYA 2022-06-03

Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile

Applicant Excellent Medical Technology Group Co., Ltd.

K-Number K220665

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JOW 2022-06-03

CIRCUL8 Connect DVT Prevention Device

Applicant Ortho8, Inc.

K-Number K220761

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