11 results · 27ms · Sources: EU EUDAMED, US FDA

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GE DEFINIUM AMX 700, MODEL AMX 700

FDA 510(k)
FDA Class 2 ·Radiology

BACT/ALERT® FA PLUS

FDA Adverse Event
Malfunction ·BIOMERIEUX INC.·Product code MDB·August 29, 2019

BACT/ALERT® FA PLUS

FDA Adverse Event
Malfunction ·BIOMERIEUX INC.·Product code MDB·August 29, 2019

PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETA·February 19, 2016

TITANIUM MIDDLE EAR PROSTHESES

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

QUIK-COMBO PACING/DEFIBRILLATION/ECG

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL CORP·Product code LDD·March 31, 1998

GENESIS

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 2, 2013

SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE

FDA Adverse Event
Malfunction ·STAAR SURGICAL·Product code HQL·May 22, 2008

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·April 13, 2011

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