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

NUH 2019-11-01

Combo Electrotherapy Device

Applicant Shenzhen Roundwhale Technology Co. , Ltd.

K-Number K192087

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EBI 2019-11-01

NextDent Denture 3D+

Applicant Vertex-Dental B.V.

K-Number K191497

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MUD 2019-11-01

MIMOSA Imager

Applicant Mimosa Diagnostics, Inc.

K-Number K190334

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KWY 2019-11-01

COPAL exchange G Hip and Knee Spacers

Applicant Heraeus Medical GmbH

K-Number K191016

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FOZ 2019-11-01

BD Acute Central Line

Applicant Bard Access Systems, Inc. (Bard Has Joined Bd)

K-Number K190855

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HQC 2019-11-01

LEGION System

Applicant Alcon Research, LLC

K-Number K191650

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HIH 2019-11-01

Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)

Applicant Uvision360, Inc.

K-Number K192278

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MQP 2019-11-01

Small VBR

Applicant Ulrich GmbH & Co. KG

K-Number K192117

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MAX 2019-11-01

XIHPOS ZFUZE Interbody Fusion System

Applicant Difusion Technologies

K-Number K190544

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KPI 2019-11-01

Perfect PFE

Applicant Tenscare, Ltd.

K-Number K191312

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LPH 2019-11-01

Delta Multihole TT Pro Acetabular System

Applicant Lima Corporate S.P.A.

K-Number K191622

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HAW 2019-11-01

Stealth Autoguide System, Midas Rex Legend Depth Stop System

Applicant Medtronic Navigation, Inc.

K-Number K191597

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