10 results
·
28ms
·
Sources: EU EUDAMED, US FDA
VARELISA GLIADIN IGG ANTIBODIES
FDA 510(k)
FDA Class 2
·Immunology
MODIFICATION TO OMEGA 21 SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
FDA 510(k)
FDA Class 2
·Ophthalmic
LOGIC CR TIB INSERT STD, SZ 3, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 14, 2024
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2011
INTRO-FLEX SHEATH INTRODUCER WITH AMC THROMBOSHIELD
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYB·May 8, 2008
HARMONY DELIVERY CATHETER SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPV·February 13, 2026
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018