Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

FYC 2021-05-20

Surgical Isolation Gown

Applicant Yanbian Pacific Textile Co., Ltd.

K-Number K203415

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FCG 2021-05-20

EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle

Applicant Cook Ireland, Ltd.

K-Number K210476

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MEH 2021-05-20

Actis DuoFix Hip Prosthesis- Collarless

Applicant Depuy Ireland UC

K-Number K210581

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KCY 2021-05-20

ATS 5000 Automatic Tourniquet Instrument

Applicant Mcewen and Associates Consulting , Ltd.

K-Number K202919

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MWI 2021-05-20

Vitals360 Multi-Vitals Mobile Monitor

Applicant Vocare, Inc.

K-Number K210086

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FAS 2021-05-19

Electrosurgical accessory

Applicant Dornier Medtech America, Inc.

K-Number K210394

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KPS 2021-05-19

Vereos PET/CT

Applicant Philips Medical Systems Nederland B.V.

K-Number K210880

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NUH 2021-05-19

TENS & EMS Device

Applicant Shenzhen Jian Feng Electronic Technology Co., Ltd.

K-Number K202866

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NKB 2021-05-19

GII Spinal Fixation System

Applicant Coligne AG

K-Number K210306

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JOJ 2021-05-19

Steam-Dot Process Indicator

Applicant Propper Manufacturing Co., Inc.

K-Number K210553

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LYY 2021-05-19

Disposable Latex Powder Free Examination Gloves (Non-sterile)

Applicant Pt. Universal Gloves

K-Number K201576

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OLO 2021-05-19

CUVIS-spine

Applicant Curexo, Inc.

K-Number K201569

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