12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System
FDA 510(k)
FDA Class 2
·Cardiovascular
HHM
FDA UDI
Oticon A/S·05707131280138·H110, DESIGNRITE 10 WL CRED HHM
RAPIDFIRE® SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036075002·
BIOPATCH 4150
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code FRO·July 22, 2015
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 29, 2023
PREVAIL DENTAL IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
REAVILLMED PRESSURE MONITORING SYSTEM AND PICC
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOPATCH 4150
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code FRO·July 22, 2015
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 6, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 9, 2008
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014