9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ALLERGY CONTROL COVERS
FDA 510(k)
FDA Class 1
·General Hospital
Brigade
FDA UDI
Nuvasive, Inc.·00887517961945·Brigade Lateral Trial, 6x34x28mm 12°
SARSTEDT NEEDLE PROTECTOR
FDA 510(k)
FDA Class 2
·General Hospital
INTERCONTINENTAL PLATE-SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
METRX® SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·January 21, 2025
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 30, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·December 14, 2012
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·November 11, 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