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

FLL 2017-09-19

Digital Thermometer

Applicant Joytech Healthcare Co. , Ltd.

K-Number K163518

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FPA 2017-09-19

Medline Blood Collection Set

Applicant Medline Industries, Inc.

K-Number K170002

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GEX 2017-09-18

LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity

Applicant Lumenis, Ltd.

K-Number K170179

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NDC 2017-09-18

Health-e-Connect System with IDA

Applicant Alr Technologies

K-Number K163664

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PBX 2017-09-18

Winback Back 3SE

Applicant Winback USA Corp

K-Number K162828

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ODP 2017-09-18

Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers

Applicant Medacta International S.A.

K-Number K172587

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CGA 2017-09-18

VITROS Chemistry Products GLU Slides

Applicant Ortho Clinical Diagnostics

K-Number K163433

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LPL 2017-09-18

Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA

Applicant Largan Medical Co., Ltd.

K-Number K170286

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ODP 2017-09-18

Shanghai Sanyou PEEK Cage System

Applicant Shanghai Sanyou Medical Co, Ltd.

K-Number K163422

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KCT 2017-09-17

Endoscope Sterilization Tray

Applicant Intuitive Surgical, Inc.

K-Number K170640

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FOZ 2017-09-17

BD Cathena Safety IV Catheter

Applicant Becton, Dickinson and Company

K-Number K172506

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MAX 2017-09-15

FLXfit™

Applicant Expanding Orthopedics, Inc.

K-Number K171519

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