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

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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GWO 2022-01-27

Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)

Applicant Osteonic Co., Ltd.

K-Number K210360

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ODP 2022-01-27

Fortilink with TiPlus Technology

Applicant Paradigm Spine

K-Number K213493

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QJI 2022-01-27

SmartAdjust technology

Applicant Insulet Corporation

K-Number K203774

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GBM 2022-01-27

Intermittent Catheter (Not Finalized)

Applicant Hollister Incorporated

K-Number K211436

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