11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SUPER QUICKANCHOR PLUS
FDA 510(k)
FDA Class 2
·Orthopedic
Entuit Thrive
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00827002356160·Entuit Gastrostomy BR Balloon Retention Feeding...
HAND-CARRIED ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
FDA 510(k)
FDA Class 2
·Microbiology
LEGION PS OXIN FEM SZ5 LT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018
ZOOM
FDA Adverse Event
Malfunction
·EXTERNAL MANUFACTURER·Product code KRG·April 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 27, 2014
STERRAD® NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 20, 2018
BABY CONTROL COSYCOT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·June 8, 2015
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