11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHOCORD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564033123·Laser Pack
SET, ADMINISTRATION, INTRAVASCULAR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016
BNX FINE NEEDLE ASPIRATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR
FDA 510(k)
FDA Class 2
·General Hospital
U-BLADE SET, TI GAMMA3 10.5X90MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 30, 2012
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 9, 2019
HICKMAN TRIFUSION 19CM STRAIGHT KIT WITH INTERMEDIATE KIT
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code LJS·May 15, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011
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