11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
KARL STORZ
FDA UDI
Tecomet·00817766024962·TRAY, TROCAR & TAKE-APART INSTRUMENTS
3 6MM TRO...
VERTE-STACK K030736, K041197
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019
SUPER NOVA, ACUBEAM
FDA 510(k)
FDA Class 2
·Physical Medicine
DELDENT ULTRASONIC INSERTS
FDA 510(k)
FDA Class 2
·Dental
CORNERSTONE-SR CAGE SYSTEM
FDA Adverse Event
Death
·MSD DEGGENDORF MFG·Product code ODP·February 17, 2012
EASYTRAK
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NIK·April 8, 2013
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIV.·Product code LGW·March 29, 2011
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 9, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018