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

LPH 2018-06-15

Trinity PLUS Acetabular Shell

Applicant Corin U.S.A. Limited

K-Number K172551

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GWE 2018-06-15

Natus Photic Stimulator

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K-Number K173936

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EGJ 2018-06-15

Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE

Applicant Hightech Development

K-Number K170835

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OUR 2018-06-15

Life Spine SIMPACT Sacroiliac Joint Fixation System

Applicant Life Spine, Inc.

K-Number K180749

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BZD 2018-06-15

Scone Mask

Applicant Resmed, Ltd.

K-Number K180497

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KRR 2018-06-14

Patello-Femoral Wave (Kahuna) Arthroplasty System

Applicant Arthrosurface, Inc.

K-Number K181280

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MMI 2018-06-14

Access hsTnl

Applicant Beckman Coulter, Inc.

K-Number K172787

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LLZ 2018-06-14

EchoMD Automated Ejection Fraction Software

Applicant Bay Labs, Inc.

K-Number K173780

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KWY 2018-06-14

SurgTech Bipolar Head System

Applicant Surgtech, Inc.

K-Number K173455

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OVD 2018-06-14

S128 Anterior Lumbar Interbody Fusion (ALIF) System

Applicant Renovis Surgical Technologies, Inc.

K-Number K180502

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DRG 2018-06-14

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)

Applicant Hmicro, Inc.

K-Number K172011

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MIA 2018-06-14

Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors

Applicant Smiths Medical Asd, Inc.

K-Number K172800

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