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

HWC 2021-05-11

DART-FIRE EDGE Cannulated Screw System

Applicant Wright Medical

K-Number K203228

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GEX 2021-05-10

Diode Laser Therapy Systems

Applicant Beijing Kes Biology Technology Co., Ltd.

K-Number K210168

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JFY 2021-05-10

Yumizen C1200 Creatinine PAP

Applicant HORIBA ABX SAS

K-Number K193649

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INI 2021-05-10

Solax Electric Scooter (Models: S204311M, S204161, S204143)

Applicant Dongguan Prestige Sporting Goods Co., Ltd.

K-Number K190737

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EKX 2021-05-10

Endo Motor

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K-Number K203320

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OVE 2021-05-10

ChoiceSpine Blackhawk Ti Cervical Spacer System

Applicant Choice Spine, LLC

K-Number K203311

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LYZ 2021-05-10

Single-use medical poly (vinyl chloride) examination glove

Applicant Anhui Bytech Medical Supplies Co., Ltd.

K-Number K201504

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KCT 2021-05-07

Karl Storz Radel Sterilization Trays

Applicant Karl Storz Endoscopy America, Inc.

K-Number K203572

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LZA 2021-05-07

Blue Nitrile Powder Free Patient Examination Glove, Non Sterile

Applicant Onetexx Sdn Bhd

K-Number K210366

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LZA 2021-05-07

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)

Applicant Central Medicare Sdn Bhd

K-Number K203036

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QLG 2021-05-07

Bigfoot Unity Diabetes Management System

Applicant Bigfoot Biomedical, Inc.

K-Number K202145

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FXX 2021-05-07

SURGICAL MASK, Model Name:C015

Applicant Qingdao Hainuo Biological Engineering Co., Ltd.

K-Number K210218

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