10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
AUTOMATED PULMONARY FUNCTION LABORATORY
FDA 510(k)
FDA Class 2
·Anesthesiology
Cochlear™ Baha® Fitting Software
FDA UDI
Cochlear Bone Anchored Solutions AB·09321502036030·Program Baha Sound Processors
VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET
FDA 510(k)
FDA Class 2
·Cardiovascular
16CH AI BREAST COILS 1.5 T AND 3 T
FDA 510(k)
FDA Class 2
·Radiology
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 9, 2014
UNKNOWN DEPUY FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code JDI·October 24, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 27, 2007
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
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024