11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
FDA 510(k)
FDA Class 2
·Immunology
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776291990·Iris Scissors
NA
FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024312357·
NA
FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024312340·
CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
FDA 510(k)
FDA Class 2
·Orthopedic
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
FDA 510(k)
FDA Class 3
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 5, 2025
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 11, 2013
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·April 13, 2011
DLC FLEX DRILL SHAFT
FDA Adverse Event
Death
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·May 22, 2008
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