Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

LZC 2022-01-28

Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs

Applicant Anhui Xinyisheng Medical Technology Co.,Ltd

K-Number K213325

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GEX 2022-01-28

Platform treatment system

Applicant Shanghai Apolo Medical Technology Co., Ltd.

K-Number K203395

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DQY 2022-01-28

QuikPass Catheter

Applicant Traverse Vascular, Inc.

K-Number K214106

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JHX 2022-01-28

VITROS Immunodiagnostic Products CK-MB Reagent Pack

Applicant Ortho Clinical Diagnostics

K-Number K212648

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LZA 2022-01-28

Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution

Applicant Shen Wei USA, Inc.

K-Number K213142

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DZE 2022-01-28

BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants

Applicant Institut Straumann AG

K-Number K212533

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FLL 2022-01-28

iHealth infrared Ear thermometer PT5

Applicant Andon Health Co, Ltd.

K-Number K212598

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DTZ 2022-01-28

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U

Applicant Qura S.R.L

K-Number K212341

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DSA 2022-01-27

9Line

Applicant Energetic Designs, Inc.

K-Number K211941

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FMF 2022-01-27

Sterile Auto-Disable Syringes with/without Needle for Single Use

Applicant Azur Medical Company, Inc.

K-Number K211210

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HRS 2022-01-27

Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate

Applicant Wishbone Medical, Inc.

K-Number K213489

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DIO 2022-01-27

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System

Applicant Carolina Liquid Chemistries Corp.

K-Number K213211

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