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

QJP 2024-05-16

Wedge XL Delivery Catheter

Applicant MicroVention, Inc.

K-Number K232542

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PNN 2024-05-16

RAYDENT SW

Applicant Ray Co., Ltd.

K-Number K233625

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DQA 2024-05-16

Sempulse Halo Vital Signs Monitor

Applicant Sempulse Corporation

K-Number K232495

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FYC 2024-05-16

Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)

Applicant Owens & Minor (O&M) Halyard, Inc.

K-Number K232849

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IPF 2024-05-16

Stimulation System (PA series, PR series, S series and Q series)

Applicant Edan Instruments, Inc.

K-Number K232786

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GEX 2024-05-16

DEKA TORO

Applicant El.En S.P.A.

K-Number K240752

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IYN 2024-05-16

HD80 Series Ultrasound Diagnostic System

Applicant Qingdao Hisense Medical Equipment Co., Ltd.

K-Number K233841

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JWY 2024-05-16

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.

Applicant Thermo Fisher Scientific

K-Number K240445

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DZE 2024-05-16

Ticare Dental Implant Systems

Applicant Mozograu S.A.

K-Number K233137

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PHR 2024-05-16

FAgamin®

Applicant Tedequim Srl

K-Number K240059

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HKI 2024-05-15

CANON Fundus Camera CR-10 (CR-10)

Applicant Canon, Inc.

K-Number K241049

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OVD 2024-05-15

E3D™-A Interbody System

Applicant Evolution Spine

K-Number K240368

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