11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
ATRICURE COOLRAIL LINEAR PEN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATRICURE BIPOLAR SYSTEM
FDA Adverse Event
Injury
·ATRICURE, INC.·Product code GEI·July 28, 2010
AEROECLIPSE II BREATH ACTUATED NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
INSCOPE 3-STAGE BALLOON DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 23, 2013
CONSTELLATION WITH LASER
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 27, 2011
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
DIMENSION EXL WITH LM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013
DIMENSION EXL 200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 23, 2013
FlexTrayTM Endopath GYN Tray, Kit code KD005.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
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