18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
FDA 510(k)
FDA Class 2
·Neurology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496013488·MARILYN 30 SHEER, SIZE M, NERO, GRADUATED COMPR...
OPHELIA ROE
FDA UDI
FGX INTERNATIONAL INC.·00708820706262·
OPHELIA ROE
FDA UDI
FGX INTERNATIONAL INC.·00193033500354·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134080·Trial, TLIF, 27L OB STR 7Deg, 8mm
ATAC PAK AST REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNCHRON CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·October 8, 2020
MICRO DRILL MEDIUM STRAIGHT ATTACHMENT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·March 20, 2013
COULTER® LH700 SERIES RETIC PAK
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GGK·March 10, 2011
MARQUIS DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·March 10, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·November 12, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·November 25, 2020
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025
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