11 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BELMONT BUDDY PLUS FLUID WARMER
FDA 510(k)
FDA Class 2
·Hematology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040064754·MOLAR BAND UL 1ST&2ND 30 (2)
JOSTRA ARTERIAL PERFUSION CANNULAE
FDA 510(k)
FDA Class 2
·Cardiovascular
HRH-63 HEAD ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 28, 2021
SYNTHES USA PLATE RIGHT FEMUR
FDA Adverse Event
SYNTHES USA·Product code HRS·April 11, 2013
WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·April 19, 2011
TRILOGY ACETABULAR SYSTEM DRILL BIT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HTW·June 17, 2008
PEEK CAGE, UNKNOWN TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·February 9, 2021
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015