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

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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IYE 2021-05-14

Klarity Bolus

Applicant Klarity Medical & Equipment (GZ) Co., Ltd.

K-Number K202747

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DRA 2021-05-14

AcQGuide MAX Steerable Sheath

Applicant Acutus Medical, Inc.

K-Number K211100

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DRT 2021-05-14

Cardiac Trigger Monitor

Applicant Ivy Biomedical Systems, Inc.

K-Number K202138

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LYZ 2021-05-14

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

Applicant Shandong Shangwei Medical Products Co., Ltd.

K-Number K210780

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FMF 2021-05-14

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock

Applicant Set Medikal Sanayi VE Ticaret Anonim Sirketi

K-Number K210200

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