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

EBG 2019-07-03

MD-Temp Plus

Applicant Meta Biomed Co., Ltd.

K-Number K190724

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IZH 2019-07-03

Biopsy Positioner

Applicant Fujifilm Corporation

K-Number K191495

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NLF 2019-07-03

Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K191018

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EBZ 2019-07-03

Bluephase PowerCure

Applicant Ivoclar Vivadent, AG

K-Number K190272

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DZE 2019-07-03

AlphaDent Implants Dental Implants System

Applicant Alphadent Implants, Ltd.

K-Number K180968

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JAK 2019-07-03

syngo.CT Dual Energy

Applicant Siemens Medical Solutions USA, Inc.

K-Number K191468

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OMP 2019-07-02

PWD Platform Wound Dressing 3 x 5 Oblong

Applicant Applied Tissue Technologies, LLC

K-Number K191460

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NHA 2019-07-02

Certain BellaTek Express and BellaTek Flex Abutments

Applicant Biomet 3i

K-Number K183138

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DQK 2019-07-02

iLab Polaris Multi-Modality Guidance System

Applicant Boston Scientific Corporation

K-Number K191008

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FAJ 2019-07-02

Uro-N Cystoscope

Applicant Uroviu Corporation

K-Number K182876

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LRK 2019-07-02

Twilite Appliance

Applicant Stephen J Harkins, Dds, PC

K-Number K190687

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MCW 2019-07-02

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System

Applicant Cardiovascular Systems, Inc.

K-Number K190634

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