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

LNH 2021-05-17

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K211037

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FPA 2021-05-17

Needleless Connector

Applicant Jiangsu Caina Medical Co.,Ltd

K-Number K210217

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GEI 2021-05-17

Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action

Applicant Olympus Winter & Ibe GmbH

K-Number K203682

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LYZ 2021-05-17

NitriTec Vinyl Glove Powder Free Blue

Applicant Zhonghong Pulin Medical Products Co., Ltd.

K-Number K210460

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LLZ 2021-05-17

Cercare Medical Neurosuite

Applicant Cercare Medical Aps

K-Number K202793

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FXX 2021-05-17

Ear-Friendly Mask

Applicant Ray Co., Ltd.

K-Number K211105

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OKO 2021-05-14

NPseal

Applicant Guard Medical, Inc.

K-Number K211130

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MQL 2021-05-14

Gx-IVF, Gx-TL, Gx-MOPS PLUS

Applicant Vitrolife Sweden AB

K-Number K202862

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LYZ 2021-05-14

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Applicant Shandong Jieshi Medical Products Co., Ltd.

K-Number K210774

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JOW 2021-05-14

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

Applicant Bio Compression Systems, Inc.

K-Number K210417

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GCM 2021-05-14

TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM

Applicant Richard Wolf Medical Instruments Corporation

K-Number K203226

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LLZ 2021-05-14

HOLOSCOPE-i

Applicant Real View Imaging , Ltd.

K-Number K210072

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