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

DRG 2023-08-10

ANNE One

Applicant Sibel Health, Inc.

K-Number K223711

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QFG 2023-08-10

Accu-Chek Solo micropump system with interoperable technology

Applicant Roche Diabetes Care GmbH

K-Number K213134

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QXL 2023-08-10

Aura 10 PET/CT

Applicant Xeos Medical

K-Number K231420

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QWR 2023-08-10

ID NOW COVID-19 2.0

Applicant Abbott Diagnostics Scarborough, Inc.

K-Number K221925

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NBW 2023-08-10

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system

Applicant Roche Diabetes Care GmbH

K-Number K213131

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DQK 2023-08-10

EnSite X EP System

Applicant ABBOTT MEDICAL

K-Number K231415

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GXQ 2023-08-10

ArtiFascia

Applicant Nurami Medical , Ltd.

K-Number K223445

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BZG 2023-08-09

Air Smart Extra Spirometer

Applicant Feellife Health, Inc.

K-Number K222443

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NIG 2023-08-09

VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack

Applicant Ortho Clinical Diagnostics

K-Number K231525

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ONF 2023-08-09

Intense Pulsed Light System

Applicant Smedtrum Medical Technology Co., Ltd.

K-Number K231394

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LZA 2023-08-09

Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Grand Work Plastic Products Co., Ltd.

K-Number K232039

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KGO 2023-08-09

Polyisoprene Surgical Gloves

Applicant Puyang Linshi Medical Supplies Co., Ltd.

K-Number K230304

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