12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAICHEM CREATININE URINE STANDARD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780781·LEVAMED ACTIVE ANKLE SUP SLVR L VI
PRECISE
FDA UDI
Stryker GmbH·00886385005997·T10 Driver w/QC connector Precise SD
InSePtion MIS Fixation System
FDA UDI
Kalitec Direct LLC·B07314K0112160·Rasp, 16 and 18 mm
PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
FDA 510(k)
FDA Class 2
·Ophthalmic
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 20, 2014
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·March 19, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·March 8, 2011
SYMMETRY DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 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