11 results
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19ms
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Sources: EU EUDAMED, US FDA
UP-DF500 FILMSTATION DIGITAL FILM IMAGER
FDA 510(k)
FDA Class 2
·Radiology
Inspire®SA 3D Printed Trabecular PEEK™ with HAFUSE®
FDA UDI
CURITEVA, INC.·B648C72430241881·30 (W) X 24 (D) X 18 (H) X 8° (A) STANDALONE AL...
BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
NEW PROPHY POWDER
FDA 510(k)
FDA Class 2
·Dental
SEE H10
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011
FOLYSIL SILICONE CATHETER
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code EZL·December 2, 2024
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON INC·Product code OTP·March 27, 2013
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·March 18, 2011
HILL-ROM 100 LOW BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·March 27, 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
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016