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

POK 2021-12-16

Koios DS

Applicant Koios Medical, Inc.

K-Number K212616

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PGY 2021-12-16

6MP Color LCD Monitor CL-S600

Applicant Jvckenwood Corporation

K-Number K212985

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LZA 2021-12-16

Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs

Applicant Rimba Glove Snd Bhd

K-Number K212898

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OHT 2021-12-16

IPL hair removal machine

Applicant Shenzhen Borria Technology Co., Ltd.

K-Number K213020

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GEI 2021-12-16

Voyant Fine Fusion Device (EB230)

Applicant Applied Medical

K-Number K202818

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FXX 2021-12-16

LM Surgical Mask Level 3, LM Surgical Mask Level 2,

Applicant Liberty Mask, LLC

K-Number K211378

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FYA 2021-12-16

Surgical Gown, Model: surgical gown-hp-3

Applicant Weihai Dishang Medical Technology Co., Ltd.

K-Number K210355

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LXB 2021-12-16

Ponto 5 SuperPower

Applicant Oticon Medical AB

K-Number K213733

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FMI 2021-12-16

UltiCare Disposable Pen Needles

Applicant Ultimed Incorporated

K-Number K213407

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GCJ 2021-12-16

Connected OR Hub with Device and Voice Control

Applicant Stryker Corporation

K-Number K212055

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LLZ 2021-12-16

Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio

Applicant Brainlab AG

K-Number K212420

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HQF 2021-12-16

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo

Applicant Ellex Medical Pty, Ltd.

K-Number K212630

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