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

JAK 2022-02-25

OmniTom Elite

Applicant Neurologica Corporation, A Subsidiary of Samsung Electronics

K-Number K211711

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LON 2022-02-25

VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole

Applicant bioMerieux, Inc.

K-Number K213241

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PHX 2022-02-25

PRIMA Humeral System and SMR Glenosphere Ø42

Applicant Lima Corporate S.P.A.

K-Number K212800

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MNR 2022-02-24

NightOwl

Applicant Ectosense NV

K-Number K220028

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FYA 2022-02-24

Bodygard SFS Surgical Gown Level 3

Applicant Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi

K-Number K202845

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QFM 2022-02-24

Annalise Enterprise CXR Triage Pneumothorax

Applicant Annalise-Ai

K-Number K213941

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NXC 2022-02-24

uLab Systems Dental Aligner Kit

Applicant Ulab Systems, Inc.

K-Number K211510

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PLR 2022-02-24

CAPRI Corpectomy Cage System

Applicant K2m, Inc.

K-Number K211320

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QEW 2022-02-24

Cleaner Plus Thrombectomy System

Applicant Argon Medical Devices, Inc.

K-Number K211798

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JAK 2022-02-24

Epione

Applicant Quantum Surgical Sas

K-Number K211645

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FRO 2022-02-24

PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing

Applicant 3M Healthcare Business Group

K-Number K210135

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GEI 2022-02-24

ArtiSential Laparoscopic Instruments-Electrodes

Applicant Livsmed, Inc.

K-Number K220384

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