20 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IM60/IM70 PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTEC OS SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
FDA 510(k)
FDA Class 2
·Orthopedic
MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X8 L°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·September 14, 2018
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·June 14, 2023
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
EPICARDIAL PATCH
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·June 16, 2011
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·August 21, 2008
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·December 17, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·June 16, 2022
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 11, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 8, 2022
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·March 19, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·October 8, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 28, 2021
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 28, 2022
DRETLER UNIVERSAL URETEROSCOPY STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·February 22, 2022
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·February 9, 2022
GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
FDA Enforcement
Class II
·Terminated·GE Healthcare·April 11, 2018
GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 19, 2019