17 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMPACT COTREL -- DUBOUSSET SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BASIS¿ SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·July 19, 2012
ASSUFIL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDEAVOR SPRINT OTW
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·December 8, 2010
STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code JDQ·January 18, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 6, 2014
LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 6, 2024
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 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