11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PF4 IGG
FDA Adverse Event
Malfunction
·IMMUCOR GTI DIAGNOSTICS·Product code GWG·January 16, 2015
PF4 IGG
FDA 510(k)
FDA Class 2
·Hematology
INTERCEPT-URETHRAL MICROCOIL
FDA 510(k)
FDA Class 2
·Radiology
CURRY MULTIMODAL NEUROIMAGING SOFTWARE
FDA 510(k)
FDA Class 2
·Neurology
COCR FEMORAL HEAD
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·February 23, 2018
ADVISA DR
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NVZ·April 22, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·April 21, 2011
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·July 7, 2008
MEDICAL DEVICE BRAND NAME
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·August 30, 2018
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
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