15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOLIX
FDA 510(k)
FDA Class 2
·Ophthalmic
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
FDA 510(k)
FDA Class 2
·Neurology
Senhance Surgical System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code JPA·February 4, 2010
1222166-2007-00292
FDA Adverse Event
Malfunction
·Product code KSZ·June 7, 2007
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
TPRLC 133 FP TYPE1 PPS HO 6.0 T1
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·December 16, 2021
INTERSTIM II
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·November 6, 2008
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·August 24, 2011
4000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 2, 2013
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code JPA·May 13, 2010
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code JPA·May 13, 2010
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code JPA·May 13, 2010
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
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025