10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Perfit CL
FDA 510(k)
FDA Class 2
·Dental
Auxilock Titanium Interference Screw
FDA 510(k)
FDA Class 2
·Orthopedic
DEMETECH SILK NONABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN DEPUY ACETABULAR LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 4, 2014
UNKNOWN
FDA Adverse Event
Injury
·UNK·Product code FTL·August 16, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 12, 2013
OSSEOTITE® CERTAIN® IMPLANT 5 X 10MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·June 27, 2019
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
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025