12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMI·January 29, 2019
TETRIS SPINAL IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
KETAC CEM U
FDA 510(k)
FDA Class 2
·Dental
RENAL UROLOGY STENT K072293
FDA Adverse Event
Other
·FOSSA MEDICAL INC·Product code FAD·April 10, 2014
BD ULTRA FINE¿ PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMI·December 17, 2018
G7 POSITIONING GUIDE ROD
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LXH·November 13, 2024
NAVIGATION SYSTEM II - CART
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAW·April 23, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·April 29, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·October 7, 2010
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