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

LNH 2022-10-27

uMR Omega with uWS-MR-MRS

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K220332

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HSB 2022-10-27

Artemis Proximal Femoral Nail System

Applicant Glw, Inc.

K-Number K221489

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KDI 2022-10-27

2008T BlueStar Hemodailysis Machine

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K222952

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LRK 2022-10-27

CUSTMBITE Snoring System

Applicant Dental Choice Holdings, LLC

K-Number K221322

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HWC 2022-10-27

CurvaFix IM System

Applicant Curvafix, Inc.

K-Number K222505

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NHA 2022-10-27

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K222288

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DZE 2022-10-27

S.I.N. Dental Implant System

Applicant S.I.N. - Sistema DE Implante Nacional S.A.

K-Number K222231

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LFZ 2022-10-27

Architect CMV IgG

Applicant Abbott Laboratories

K-Number K220949

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HRS 2022-10-27

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System

Applicant Hospital Equipment Manufacturing Company

K-Number K222282

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OYJ 2022-10-27

ORAcollect®Dx

Applicant DNA Genotek, Inc.

K-Number K212745

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KCT 2022-10-27

S.I.N. Instrument Kits

Applicant S.I.N. Sistema DE Implante Nacional S.A.

K-Number K222514

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PTA 2022-10-27

AlphaID At Home Genetic Health Risk Service

Applicant Progenika Biopharma S.A., A Grifols Company

K-Number K221420

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