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

MOS 2022-12-08

8ch Wrist Coil

Applicant Shenzhen RF Tech Co., Ltd.

K-Number K223239

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JDW 2022-12-08

MAVERICK Mini External Fixation System

Applicant Smith & Nephew, Inc.

K-Number K223112

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KWQ 2022-12-07

OAKTREE Anterior Lumbar Plate and Screw System

Applicant Oak Tree Engineering, LLC

K-Number K220843

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QBJ 2022-12-07

Dexcom G7 Continuous Glucose Monitoring System

Applicant Dexcom, Inc.

K-Number K213919

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LZA 2022-12-07

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate

Applicant Jr Engineering & Medical Technologies (M) Sdn. Bhd.

K-Number K221626

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EZD 2022-12-07

PVC Hydrophilic Urethral Catheter

Applicant Chengdu Daxan Innovative Medical Tech. Co., Ltd.

K-Number K212567

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FOZ 2022-12-07

HydroMID 4F Single Lumen Midline Catheter

Applicant Access Vascular, Inc.

K-Number K220772

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IYN 2022-12-07

Ultrasound System 2300

Applicant Bk Medical Aps

K-Number K222441

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CAH 2022-12-07

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus

Applicant Drägerwerk AG & Co. KGaA

K-Number K221836

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OBJ 2022-12-07

ViewFlex Xtra ICE Catheter

Applicant Irvine Biomedical, A St. Jude Medical Company

K-Number K223077

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LZA 2022-12-07

Disposable Nitrile Examination Glove

Applicant Anhui Kindguard Medical Supplies Technology Co., Ltd.

K-Number K223281

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QSE 2022-12-07

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF

Applicant Roche Diagnostics

K-Number K221842

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