14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
CENTRICITY PACS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134150·Trial, TLIF, 27L OB STR 7Deg, 15mm
BD 1ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 18, 2020
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES ANKLE ARTHRODESIS PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
NUVASIVE
FDA Adverse Event
Injury
·NUVASIVE·Product code NKB·January 10, 2011
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 12, 2013
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 15, 2011
INSIGNIA ENTRA
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Injury
·COOK INC·Product code EZN·May 21, 2019
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 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