12 results · 24ms · Sources: EU EUDAMED, US FDA

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MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM

FDA 510(k)
FDA Class 1 ·Ophthalmic

MAGNETOM TRIO SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES

FDA 510(k)
FDA Class 2 ·Ophthalmic

LUX 1440

FDA Adverse Event
Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

TRUWAVE, VAMP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVAMEX·Product code IOR·April 23, 2013

ATLAS DR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

SI BRITE TIP

FDA Adverse Event
Malfunction ·CORDIS DE MEXICO·Product code DYB·May 2, 2011

TRUWAVE, VAMP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025

TRUWAVE, VAMP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

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

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