20 results · 28ms · Sources: EU EUDAMED, 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