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

NUH 2019-07-30

Transcutaneous Electrical Nerve Stimulator

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K-Number K183288

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GEI 2019-07-30

Renuvion/J-Plasma Precise Handpiece

Applicant Apyx Medical Corporation(Formerly Bovie Medical Corporation)

K-Number K191484

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ODP 2019-07-30

Addivation Medical Cervical Interbody System

Applicant Addivation Medical, LLC

K-Number K190291

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JKA 2019-07-30

Blood Transfer Accessory (BTA)

Applicant Nsp Tech Pte, Ltd.

K-Number K181743

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DXN 2019-07-29

Non-invasive blood pressure measurement systems

Applicant Joytech Healthcare Co. , Ltd.

K-Number K190886

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OAP 2019-07-29

Hair Boom 69

Applicant Wontech

K-Number K191154

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HWC 2019-07-29

Bone Screw Line Addition

Applicant Vilex IN Tennessee, Inc.

K-Number K191289

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IYE 2019-07-29

BiomarC Fiducial Marker

Applicant Carbon Medical Technologies

K-Number K191797

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EBC 2019-07-29

Helioseal F Plus

Applicant Ivoclar Vivadent, AG

K-Number K190339

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LSR 2019-07-29

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System

Applicant Zeus Scientific, Inc.

K-Number K191240

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LSR 2019-07-29

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System

Applicant Zeus Scientific, Inc.

K-Number K190907

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PJD 2019-07-29

Quantisal II Oral Fluid Collection Device

Applicant Immunalysis Corporation

K-Number K183048

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