14 results · 20ms · Sources: EU EUDAMED, US FDA

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WELCH ALLYN ABPM 6100

FDA 510(k)
FDA Class 2 ·Cardiovascular

ADMIRA FLOW

FDA 510(k)
FDA Class 2 ·Dental

LUNAR REPORT GENERATOR II

FDA 510(k)
FDA Class 2 ·Radiology

MODIFIED KUGEL PATCH

FDA Adverse Event
Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 7, 2010

MODIFIED KUGEL PATCH

FDA Adverse Event
Malfunction ·DAVOL INC.·Product code FTL·September 1, 2011

COAGUCHEK® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·March 26, 2013

DEPUY

FDA Adverse Event
Injury ·DEPUY PINNACLE·Product code KWA·March 11, 2011

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·March 19, 2008

MODIFIED KUGEL PATCH

FDA Adverse Event
Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·June 27, 2013

MODIFIED KUGEL PATCH

FDA Adverse Event
Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 25, 2016

MODIFIED KUGEL PATCH

FDA Adverse Event
Injury ·DAVOL INC·Product code FTL·August 2, 2011

Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and 021756 hand controller. The device is indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Recall
Terminated ·Accuray Inc·Product code IYE·May 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

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014