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

DQX 2021-12-08

ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20

Applicant Asahi Intecc Co., Ltd.

K-Number K211898

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LZC 2021-12-08

Disposable Medical Nitrile Examination Gloves (Non sterile)

Applicant Jiangsu Nanfang Medical Co., Ltd.

K-Number K212639

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GEX 2021-12-08

PicoLO Premium

Applicant Laseroptek Co., Ltd.

K-Number K212573

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FMI 2021-12-08

BD Nano 2nd Gen Pen Needle

Applicant Becton, Dickinson and Company

K-Number K213156

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MAX 2021-12-08

Anteralign Spinal System with Titan nanoLOCK Surface Technology

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K212524

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FLL 2021-12-08

Infrared forehead thermometer LD-FT-100B

Applicant Honsun (Nantong) Co., Ltd.

K-Number K211629

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OCW 2021-12-07

endomina system

Applicant Endo Tools Therapeutics S.A.

K-Number K211309

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FXX 2021-12-07

BAYLAB 3-Ply Surgical Mask (BEACON I)

Applicant Baylab USA, LLC

K-Number K212302

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IYO 2021-12-07

Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42

Applicant Infraredx, Inc.

K-Number K213303

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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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