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 2017-08-16

EXCELSIUS GPS

Applicant Globus Medical, Inc.

K-Number K171651

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EBZ 2017-08-16

Clear Blue Digi LED Curing Light

Applicant Promident, LLC

K-Number K172426

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KWS 2017-08-16

Medacta Anatomic Shoulder Prosthesis

Applicant Medacta International S.A.

K-Number K170910

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NKB 2017-08-16

CapSure® PS System

Applicant Spine Wave, Inc.

K-Number K172175

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EFB 2017-08-15

PANA SPRAY Plus

Applicant Nakanishi, Inc.

K-Number K163483

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LAF 2017-08-15

Rapid Tox Cup II

Applicant American Bio Medica Corp.

K-Number K170222

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DIO 2017-08-15

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)

Applicant Carolina Liquid Chemistries Corporation

K-Number K163570

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FXX 2017-08-15

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield

Applicant Prestige Ameritech

K-Number K171162

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BSZ 2017-08-15

Aisys CS2

Applicant Datex-Ohmeda, Inc.

K-Number K170872

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FPA 2017-08-15

Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)

Applicant Cair Lgl

K-Number K171118

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IYN 2017-08-15

ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K172374

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MUJ 2017-08-15

Eclipse Treatment Planning System

Applicant Varian Medical Systems, Inc.

K-Number K172163

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