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

OAP 2018-10-26

Hair Laser Headband

Applicant Pulsaderm, LLC

K-Number K182501

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QBC 2018-10-25

External upper limb tremor stimulator

Applicant Cala Health, Inc.

K-Number K182706

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GBM 2018-10-25

SpeediCath Standard

Applicant Coloplast

K-Number K180258

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JXG 2018-10-25

Codman Certas Plus Electronic Tool Kit

Applicant Integra Lifesciences Corp.

K-Number K181902

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LLZ 2018-10-25

PeekMed

Applicant Peek Health, S.A.

K-Number K182464

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NGX 2018-10-25

SLENDERTONE CoreFit Abs 8, Type 734

Applicant Bio-Medical Research, Ltd.

K-Number K180688

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GWG 2018-10-25

CONVIVO

Applicant Carl Zeiss Meditec, AG

K-Number K181116

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DXT 2018-10-25

DyeVert PLUS EZ Contrast Reduction System

Applicant Osprey Medical, Inc.

K-Number K181936

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NRY 2018-10-25

074 Zenith Flex System

Applicant Inneuroco, Inc.

K-Number K181354

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HJK 2018-10-25

Endocular Viewing Lenses and Silicone Ring

Applicant Phakos

K-Number K173944

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JDW 2018-10-25

SMV Scientific K-Wire and Pins

Applicant Summit Medventures

K-Number K182171

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FLL 2018-10-25

Swaive Thermometer SWT1A

Applicant E-Care Technology Co., Ltd.

K-Number K170723

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