9 results
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21ms
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Sources: EU EUDAMED, US FDA
COSTORSOL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS
FDA 510(k)
FDA Class 2
·Radiology
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM
FDA Adverse Event
Other
·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005
ANEURX ADVANTAGE BIFURCATED STENT GRAFT - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 29, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 10, 2011
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE TRAOCULA
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code HQL·July 29, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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