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

HRX 2019-01-16

Pristine Scope

Applicant Pristine Surgical

K-Number K183165

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HSB 2019-01-16

Estremo Citieffe Nailing System

Applicant Citieffe S.R.L.

K-Number K181540

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MQB 2019-01-16

Carestream DRX-1 System with DRX Core Detectors

Applicant Carestream Health, Inc.

K-Number K183474

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KWQ 2019-01-16

4CIS® Pinehurst Anterior Cervical Plate system

Applicant Solco Biomedical Co., Ltd.

K-Number K182489

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MQS 2019-01-16

Dosis SAM

Applicant Dosis, Inc.

K-Number K180410

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FYA 2019-01-16

Disposable Ultra Reinforced Surgical Gown

Applicant Xiantao Rayxin Medical Products Co., Ltd.

K-Number K173847

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OAP 2019-01-16

Laser Hair Therapy

Applicant Omm Imports, Inc. D/B/A Zero Gravity

K-Number K183329

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FOZ 2019-01-16

Merit RadialFlo Arterial Catheter

Applicant Merit Medical Singapore Pte. , Ltd.

K-Number K182538

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MQP 2019-01-16

T2 STRATOSPHERE Expandable Corpectomy System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K183510

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FGB 2019-01-16

URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

Applicant Olympus Medical Systems Corp.

K-Number K181451

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GEI 2019-01-16

SIRA RFA Electrosurgical Device

Applicant Innoblative Designs, Inc.

K-Number K181071

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PDJ 2019-01-16

HbA1c Advanced

Applicant Beckman Coulter Ireland, Inc.

K-Number K182651

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