22 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Corin TriFit TS Hip
FDA 510(k)
FDA Class 2
·Orthopedic
VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
HPR EMOLLIENT FOAM
FDA 510(k)
FDA Unclassified
·Unknown
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 8, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 8, 2013
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·July 8, 2011
GMK SPHERE TIBIAL INSERT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2017
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
NESTER PLATINUM EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·June 14, 2020
NESTER PLATINUM EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·February 19, 2020
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 15, 2023
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 9, 2023
Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Artis zee biplane, Model Number 10094141
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
Artis zee biplane, Model Number 10094141
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. .
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 1, 2015
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014