Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 2022-08-06

Pro Guard Nitrile Powder Free Examination Glove

Applicant Medical Glove Co., Ltd.

K-Number K213934

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NLH 2022-08-06

Reprocesses Umbilical Cable

Applicant Innovative Health, LLC

K-Number K221854

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OVE 2022-08-05

Unispace SA Cervical Cage

Applicant Edisoninno Co., Ltd.

K-Number K213791

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LPL 2022-08-05

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

Applicant Dk Medivision Co., Ltd.

K-Number K220045

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LZA 2022-08-05

Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

Applicant Rubberex Alliance Products Sdn Bhd

K-Number K221350

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LZA 2022-08-05

Powder Free Chloroprene Examination Glove Coloured (Blue, Green)

Applicant Careglove Global Sdn. Bhd.

K-Number K213993

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OLO 2022-08-05

Spineology Navigation Instruments

Applicant Spineology, Inc.

K-Number K213876

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GAM 2022-08-05

MONOFIX PGCL, knotless wound closure device

Applicant Samyang Holdings Corp., Ltd.

K-Number K212810

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HIS 2022-08-05

FAMA Male Latex Condoms

Applicant Shanghai Personage Hygiene Products Co., Ltd.

K-Number K220576

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OUP 2022-08-05

Avéli

Applicant Revelle Aesthetics, Inc.

K-Number K221336

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LLZ 2022-08-05

Neurophet SCALE PET

Applicant Neurophet., Inc.

K-Number K221405

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PKL 2022-08-04

MANTIS Clip

Applicant Boston Scientific Corporation

K-Number K221124

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