8 results · 26ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

OSS LES PROXIMAL FEMORAL COMPONENT

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

UNKNOWN IMPLANTABLE PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·April 26, 2013

KNIFE

FDA Adverse Event
Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·April 22, 2011

REZOOM

FDA Adverse Event
Malfunction ·ADVANCED MEDICAL OPTICS, INC.·Product code HQL·July 7, 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

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018