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

DXQ 2022-05-18

WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203

Applicant Wenzhou Xikang Medical Instruments Co., Ltd.

K-Number K212416

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KNT 2022-05-18

Siren SGT

Applicant Tools For Surgery, LLC

K-Number K220218

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HRS 2022-05-18

Osteotomy Truss System (OTS)

Applicant 4Web Medical, Inc.

K-Number K220463

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LZA 2022-05-18

Nitrile Powder Free Examination Gloves

Applicant Hebei Kangxida Medical Technology Development Co., Ltd.

K-Number K220211

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FYA 2022-05-18

Medline Orbis LVL 3 Surgical Gown

Applicant Medline Industries, LP

K-Number K220333

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GEX 2022-05-18

The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories

Applicant Lumenis Be, Ltd.

K-Number K220467

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LZA 2022-05-18

Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)

Applicant Pt. Maja Agung Latexindo

K-Number K212408

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FMK 2022-05-18

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler

Applicant Gri-Alleset, Inc.

K-Number K220917

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HRS 2022-05-17

SternaLock Sternal Closure System

Applicant Biomet Microfixation

K-Number K212782

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QJP 2022-05-17

Imperative Care Radial 088 Access System

Applicant Imperative Care, Inc.

K-Number K220807

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OOE 2022-05-17

CATALYS Precision Laser system

Applicant Amo Manufacturing USA, LLC

K-Number K220516

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OHS 2022-05-17

Skin Care Beauty Mask (Model: MJ-06)

Applicant Shenzhen Kaiyan Medical CO , Ltd.

K-Number K220168

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