11 results
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20ms
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Sources: EU EUDAMED, US FDA
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003672·KoKo Standard Pulmonary Function Filter, White ...
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003696·KoKo Standard White Filter Kit with Nose Clip a...
LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES
FDA 510(k)
FDA Class 3
·Cardiovascular
EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LOCKING CALCANEAL PLATE MINI-RIGHT
FDA Adverse Event
Injury
·WRIGHTS LANE : SYNTHES USA PRODUCTS LLC·Product code LXT·February 8, 2018
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·March 20, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·February 16, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNET CORP·Product code CBK·March 26, 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