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

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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DTN 2024-05-15

MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 800 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 1600 mL

Applicant Medtronic Cardiac Surgery

K-Number K241053

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OLX 2024-05-15

TRIUX neo (NM27000N ); MEGreview (SW26241N-B)

Applicant Megin OY

K-Number K233985

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QIH 2024-05-15

BriefCase-Quantification

Applicant Aidoc Medical , Ltd.

K-Number K241112

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PHX 2024-05-15

Full Wedge Lateralized and Augmented Baseplates

Applicant Fx Shoulder USA, Inc.

K-Number K240278

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NHA 2024-05-15

BruxZir® NOW SRC

Applicant Prismatik Dentalcraft, Inc.

K-Number K231940

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PHX 2024-05-15

Augment Off-Axis Instrument System

Applicant Fix Surgical

K-Number K241043

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