8 results
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18ms
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Sources: EU EUDAMED, US FDA
PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RADIOGRAPHIC MARKERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SUPERCROSS CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
7.0MM TI DUAL-OPENING SCREW 50MM THRD LENGTH F/6.0MM RODS
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·March 26, 2013
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·February 25, 2011
DTC MARGRON HIP REPLACEMENT SYSTEM
FDA Adverse Event
Malfunction
·PORTLAND ORTHOPAEDICS LTD.·Product code HTO·March 28, 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