11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KALIX II IMPLANT, MODEL 141 0XX WITH XX
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707065807·EXTRAORAL ELASTIC KIT
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 5, 2025
VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·January 14, 2019
TAXUS¿ LIBERTÉ¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 11, 2013
CONCERTO II CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·April 13, 2011
BIOPATCH ANTIMICROBIAL DRESSING, 1" DISK
FDA Adverse Event
Other
·INTEGRA NEUROSCIENCES, PR·Product code FRO·May 23, 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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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