15 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ENDOTOOL DRUG DOSE CALCULATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00531371·
ALGO 3 NEWBORN HEARING SCREENER
FDA 510(k)
FDA Class 2
·Neurology
PHILIPS EASYVISION WORKSTATION RELEASE 6
FDA 510(k)
FDA Class 2
·Radiology
FINELINE I
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 11, 2013
PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·May 19, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
G7 OSSEOTI MULTIHOLE 74MM J
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 21, 2023
G7 SCREW 6.5MM X 25MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·August 21, 2023
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 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