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

LSR 2020-04-06

Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit

Applicant Gold Standard Diagnostics

K-Number K200025

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LSR 2020-04-06

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

Applicant Gold Standard Diagnostics

K-Number K200023

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ODP 2020-04-06

Tryptik Ti

Applicant Spineart

K-Number K200312

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DXQ 2020-04-06

Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer

Applicant Honsun (Nantong) Co., Ltd.

K-Number K192500

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MUJ 2020-04-03

Eclipse Treatment Planning System v16.0

Applicant Varian Medical Systems, Inc.

K-Number K200608

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NVE 2020-04-03

RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector

Applicant STERIS Corporation

K-Number K200577

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HET 2020-04-03

LAP-iX Suction Irrigation

Applicant Sejong Medical Co., Ltd.

K-Number K200638

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JOW 2020-04-03

Aria System

Applicant Inova Labs

K-Number K200564

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GCJ 2020-04-03

Visera Elite II Video System Center, Visera Elite II Endoeye 3D

Applicant Olympus Medical Systems Corp.

K-Number K193026

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PSQ 2020-04-03

ADAPT Tissue

Applicant Admedus Regen Pty, Ltd.

K-Number K200566

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GEX 2020-04-03

Diode Laser Hair Removal Machine

Applicant Beijing Lead Beauty S & T Co., Ltd.

K-Number K192735

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OWB 2020-04-03

FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System

Applicant Livermoretech, Inc.

K-Number K200022

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