10 results · 29ms · Sources: EU EUDAMED, US FDA

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INTEGRAPH FLASH, MODEL CI 110

FDA 510(k)
FDA Class 2 ·General Hospital

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04047872673181·LEVAMED STABILI-TRI ANK BLU R II

VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)

FDA 510(k)
FDA Class 2 ·Cardiovascular

STRYKER NAVIGATION SYSTEM - ENT MODULE

FDA 510(k)
FDA Class 2 ·Neurology

MAGELLAN

FDA Adverse Event
Malfunction ·CARDINAL HEALTH, INC.·Product code FMI·September 6, 2023

DHF 06 HEMOCONCENTRATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALY·Product code KDI·May 22, 2025

R SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 22, 2013

NOVOPEN 4 (INSULIN DELIVERY DEVICE) NA

FDA Adverse Event
Malfunction ·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMF·March 2, 2011

COBAS 6000 501 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CEM·March 12, 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