8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6
FDA 510(k)
FDA Class 2
·Cardiovascular
THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
FDA 510(k)
FDA Class 2
·Hematology
VENTVIEW, MODEL 8414095
FDA 510(k)
FDA Class 2
·Anesthesiology
FORTIFY DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014
SD/PD LONG STRAIGHT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·May 3, 2013
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 27, 2011
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024