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

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ANTERIOR STABILIZED TIBIAL BEARINGS

FDA 510(k)
FDA Class 2 ·Orthopedic

GOOD LUBRICATIONS

FDA 510(k)
FDA Class 1 ·General Hospital

MEDPOR PTERIONAL SURGICAL IMPLANT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

LEAD MODEL 302

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·March 27, 2013

AVAULTA BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code FTL·January 26, 2011

COMPACT LOW IMPEDANCE LEAD

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·April 1, 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

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012