8 results
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19ms
·
Sources: EU EUDAMED, US FDA
SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC
FDA 510(k)
FDA Class 1
·Anesthesiology
THERMAL MASSAGE BED, MODEL 2D-GX
FDA 510(k)
FDA Class 2
·Physical Medicine
STELKAST PROVEN KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·March 24, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·October 23, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 17, 2010
Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 30, 2018
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