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

OLO 2024-04-05

Virage® Navigation System

Applicant Zimvie Spine (Zimmer Biomet Spine, Inc.)

K-Number K240647

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FLL 2024-04-05

Wireless Smart Thermometer

Applicant Famidoc Technology Company Limited

K-Number K233192

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DPS 2024-04-05

MCG-S (AM1000)

Applicant Amcg Co., Ltd.

K-Number K232823

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QZZ 2024-04-05

ELEOSx Limb Salvage System

Applicant Onkos Surgical

K-Number DEN210058

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OHS 2024-04-05

Wrinkle Treatment Device (JM2)

Applicant Shenzhen Qianyu Technology Co., Ltd.

K-Number K240360

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MAX 2024-04-05

icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage)

Applicant Icotec AG

K-Number K232792

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QKM 2024-04-05

Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

Applicant Terragene S.A.

K-Number K232103

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QZY 2024-04-05

Orthobond Mariner Pedicle Screw System

Applicant Orthobond Coporation

K-Number DEN220015

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QBP 2024-04-05

ACTIV Cap

Applicant Cleansite Medical, Inc.

K-Number K223914

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LCX 2024-04-05

ACESO Early Pregnancy Test

Applicant Aceso Laboratories, Inc.

K-Number K234152

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SAQ 2024-04-05

Symani Surgical System

Applicant Mmi North America, Inc.

K-Number DEN230032

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MQP 2024-04-04

KONG®-TL VBR System and KONG® C VBR System

Applicant Icotec AG

K-Number K232790

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