10 results · 21ms · Sources: EU EUDAMED, US FDA

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STALIF (TM) C

FDA 510(k)
FDA Class 2 ·Orthopedic

AURIS AEP

FDA 510(k)
FDA Class 2 ·Neurology

POWERDRIVE 350 OPTION

FDA 510(k)
FDA Class 2 ·Radiology

4.5MM CANNULATED SCREW FULLY THREADED/56MM

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HWC·April 23, 2013

6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2011

DA+ C SERIES SR

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DXY·July 10, 2008

LIFEPAK CR(R) PLUS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 21, 2017

PANEL PHOENIX NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 22, 2023

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

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015