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

OLI 2020-12-18

UltraSlim Digital, UltraSmooth Digital

Applicant Ward Photonics, LLC

K-Number K202361

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GEI 2020-12-18

ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System

Applicant ArthroCare Corporation

K-Number K202006

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NKB 2020-12-17

PERLA TL Posterior Osteosynthesis System

Applicant Spineart

K-Number K203222

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EBG 2020-12-17

Aidite PMMA

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K190217

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NUC 2020-12-17

pjur WOMAN Nude pjur med SENSITIVE glide

Applicant Pjur Group Luxembourg S.A.

K-Number K200730

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GEX 2020-12-17

Primelase Excellence

Applicant High Technology Products S.L.U

K-Number K201594

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FMF 2020-12-17

S dispensing line

Applicant Aea Srl

K-Number K192770

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DXN 2020-12-17

Wrist Type Blood Pressure Monitor

Applicant Avita Corporation

K-Number K200346

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NEY 2020-12-17

Emprint SX Ablation Platform with Thermosphere Technology

Applicant Covidien, LLC

K-Number K203303

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MPN 2020-12-17

Exofin High Viscosity Topical Skin Adhesive

Applicant Chemence Medical, Inc.

K-Number K200264

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DQK 2020-12-17

AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter

Applicant Philips Medical System Nederland B.V.

K-Number K201081

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MBF 2020-12-17

SMR 140° Reverse Humeral Body

Applicant Lima Corporate S.P.A.

K-Number K201905

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