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

HEB 2022-04-21

Tempo Tampon

Applicant Dong-A Pharmaceutical Co., Ltd.

K-Number K212277

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PHL 2022-04-21

GEMS-H

Applicant Samsung Electronics Co., Ltd.

K-Number K213452

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IZL 2022-04-21

GM85

Applicant Samsung Electronics Co., Ltd.

K-Number K220175

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EBF 2022-04-21

Venus Bulk Flow ONE

Applicant Kulzer, LLC

K-Number K220605

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LZA 2022-04-21

Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple

Applicant Jiangsu Bytech Medical Supplies Co., Ltd.

K-Number K220382

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OOE 2022-04-21

FEMTO LDV Z8 Femtosecond Surgical Laser

Applicant Sie Ag,Surgical Instrument Engineering

K-Number K213559

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PHX 2022-04-21

INHANCE™ Reverse Shoulder System

Applicant Depuy Ireland UC

K-Number K212737

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QEY 2022-04-20

EKOS+ Endovascular Device

Applicant Boston Scientific

K-Number K220866

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OAP 2022-04-20

Auxo A300, A150 and APod

Applicant Auxo Hair, LLC

K-Number K220543

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DPW 2022-04-20

GEM FLOW COUPLER Monitor (GEM1020M-2)

Applicant Synovis Micro Companies Alliance, Inc.

K-Number K213974

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QKM 2022-04-20

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

Applicant 3M Company

K-Number K212022

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GCJ 2022-04-20

Saberscope5 Laparoscope

Applicant Xenocor, Inc.

K-Number K220872

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