10 results
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19ms
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Sources: EU EUDAMED, US FDA
ISIS MER SYSTEM/ELEKTA MER SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809874969·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7403042208·22mm x 80mm Portal Tube
OBC-250-PAN BREAST ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
FDA 510(k)
FDA Class 2
·Immunology
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP·Product code DSQ·April 4, 2013
ZMR HIP XL TAPER STEM
FDA Adverse Event
Malfunction
·ZIMMER INC·Product code LPH·February 15, 2011
VITALITY DR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
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