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

ODP 2020-03-20

icotec Cervical Cage

Applicant Icotec AG

K-Number K192897

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EBF 2020-03-20

DIAFIL & DIAFIL Capsule

Applicant DiaDent Group International

K-Number K192510

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GEX 2020-03-20

Q Switched Nd: YAG Laser machine

Applicant Beijing Lead Beauty S & T Co., Ltd.

K-Number K193609

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JWY 2020-03-20

MTS Omadacycline 0.002 - 32 ug/mL

Applicant Liofilchem s.r.l.

K-Number K200180

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KRD 2020-03-20

AZUR Vascular Plug

Applicant MicroVention, Inc.

K-Number K191680

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FYA 2020-03-20

Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve

Applicant Cardinal Health200, LLC

K-Number K193327

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DPS 2020-03-20

AI-ECG Tracker

Applicant Shenzhen Carewell Electronics Co., Ltd.

K-Number K200036

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GCJ 2020-03-20

EnlightenVue Microendoscopy System

Applicant Enlightenvue, Inc.

K-Number K192300

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NKB 2020-03-20

Nano FortiFix® System

Applicant Nanovis Spine, LLC

K-Number K193211

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JAK 2020-03-20

Hepatic VCAR

Applicant GE Medical Systems SCS

K-Number K193281

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GEI 2020-03-20

Encision AEM Monopolar Laparoscopic Instruments and Accessories

Applicant Encision Incorporated

K-Number K191612

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NTK 2020-03-20

iTero Element 5D

Applicant Align Technology, Inc.

K-Number K193659

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