9 results
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19ms
·
Sources: EU EUDAMED, US FDA
WATSYSTEM
FDA 510(k)
FDA Class 1
·Physical Medicine
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122932·K-WIRE - DOUBLE TROCAR 1.25mm DIA x 150mm
MANUAL TILT CHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
WATERS 717 AUTOSAMPLER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·December 14, 2010
METAL CLIP
FDA Adverse Event
Injury
·Product code UNK·January 15, 2013
TENDRIL SDX
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014
LIGACLIP
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·September 26, 2017
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