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 2022-03-10

Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs

Applicant Ansell Healthcare Products, LLC

K-Number K212148

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LJE 2022-03-10

Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets

Applicant Coloplast Corp.

K-Number K211911

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PNE 2022-03-10

Reprocessed Carto Vizigo Bi-Directional Guiding Sheath

Applicant Innovative Health, LLC

K-Number K212165

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LZC 2022-03-10

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

Applicant Changzhou Universal Medical Equipment Co., Ltd.

K-Number K213910

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JGS 2022-03-10

GLP systems Track

Applicant Abbott Laboratories

K-Number K213486

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LZA 2022-03-10

Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Smart Glove Corporation Sdn. Bhd.

K-Number K213373

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FLL 2022-03-10

Infrared Forehead Thermometer, model: HS-9802D

Applicant Jiaxing Shangjia Intelligence Technology Co., Ltd.

K-Number K213038

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QFM 2022-03-10

ClearRead Xray Pneumothorax

Applicant Riverain Technologies, Inc.

K-Number K213566

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LCX 2022-03-10

One Step Pregnancy Test

Applicant Spd Swiss Precision Diagnostics GmbH

K-Number K210341

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NVK 2022-03-10

D-Laser Blue, D-Laser 16

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K-Number K210367

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LHQ 2022-03-10

Smile-100 System

Applicant Niramai Health Analytix Private Limited

K-Number K212965

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GWF 2022-03-09

SafeOp 2: Neural Informatix System

Applicant Alphatec Spine, Inc.

K-Number K213849

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