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

CCL 2022-03-17

OxyMinder

Applicant Bio-Med Devices, Inc.

K-Number K213948

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GEI 2022-03-17

Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps

Applicant Modern Medical Equipment Manufacturing, Ltd.

K-Number K210315

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DZE 2022-03-17

SICtapered & SICvantage tapered

Applicant Sic Invent AG

K-Number K210489

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FAD 2022-03-17

RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm

Applicant Ureteral Stent Company

K-Number K213444

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MUU 2022-03-16

IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit

Applicant Millennium Medical Technologies Inc (Dba Cellmyx)

K-Number K210528

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IYO 2022-03-16

EchoSK and EchoSGyn modules for EchoS Family devices

Applicant Echolight S.P.A

K-Number K212851

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NXC 2022-03-16

K Clear

Applicant Kline Europe GmbH

K-Number K220726

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GTY 2022-03-16

Healgen Strep A Rapid Test Strip (Throat Swab)

Applicant Healgen Scientific,, LLC

K-Number K212623

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QKV 2022-03-16

iTEAR100 Neurostimulator

Applicant Olympic Ophthalmics

K-Number K213623

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QIH 2022-03-16

Customize

Applicant 3D-Side S.A.

K-Number K213779

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GEX 2022-03-16

Fiber Dust PRO

Applicant Quanta System Spa

K-Number K220426

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KWQ 2022-03-16

AccuFit Lateral 2-Hole Plate

Applicant Precision Spine, Inc.

K-Number K220324

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