8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
IMPRESSIX
FDA 510(k)
FDA Class 2
·Dental
SPIFE LD-12 KIT, MODEL 3338
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
VALIANT THORACIC
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·April 11, 2013
SM104 M-SERIES W/5TH WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 16, 2011
CC IRON/MAGNESIUM CALIBRATOR
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JGJ·May 22, 2008
LABOR & DELIVERY PACK, Model Nos LLLD19H
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·March 26, 2025
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