9 results
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18ms
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Sources: EU EUDAMED, US FDA
SPONGE COUNTER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AUTOSCEPTOR IDENTIFICATION SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
INTEGRAL TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ATTAIN STARFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
UNKNOWN RIGHT HIP STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·January 16, 2013
QUICKSITE LV
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 10, 2014
PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE
FDA Adverse Event
Malfunction
·WRIGHTS LANE: SYNTHES USA PRODUCTS LLC·Product code HTE·January 5, 2018
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024