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

LYY 2021-12-07

Comfortpro

Applicant Thai Rubber Industry Company Limited

K-Number K212438

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OMD 2021-12-07

DERMABOND PRINEO Skin Closure System

Applicant ETHICON, Inc.

K-Number K213512

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LZC 2021-12-06

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs

Applicant Jr Engineering & Medical Technologies (M) Sdn. Bhd.

K-Number K212827

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ODG 2021-12-06

Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K212852

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ODP 2021-12-06

CHENA-C Spacer System

Applicant Kahtnu Surgical, Inc.

K-Number K213115

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MBI 2021-12-06

VersaTap, VersaLat, DueLock, VersaTi, MiniTi

Applicant Ortho-Design (Pty), Ltd.

K-Number K212381

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EIH 2021-12-06

LUXEN CL Dental Liquid

Applicant Dentalmax Co., Ltd.

K-Number K212548

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JAK 2021-12-06

Al-Rad Companion (Pulmonary)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K213096

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EBF 2021-12-06

3Delta Crown

Applicant Deltamed GmbH

K-Number K211804

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LPL 2021-12-06

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses

Applicant Pegavision Corporation

K-Number K211448

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FXX 2021-12-06

PMW01 Procedure Mask Level 1

Applicant Defender Safety, Inc.

K-Number K211772

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FXX 2021-12-06

Surgical Face Mask

Applicant Shanghai Yunqing Industrial Co., Ltd.

K-Number K212235

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