12 results
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20ms
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Sources: EU EUDAMED, US FDA
NAVIGATOR APPLICATIONS SUITE
FDA 510(k)
FDA Class 2
·Anesthesiology
KIMAX REMOTE VIEWING STATION
FDA 510(k)
FDA Class 2
·Radiology
ACCESS ULTRASENSITIVE HGH CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WIKTOR PRIME STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC INTERVENTIONAL VASCULAR·Product code MAF·May 6, 1998
WIKTOR PRIME DELIVERY SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC INTERVENTIONAL VASCULAR·Product code MAF·May 6, 1998
WAVEWRITER ALPHA? PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 28, 2026
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·April 29, 2013
DUROM ACETABULAR COMPONENT
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·April 28, 2011
KINETRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·July 24, 2008
MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·October 23, 2013
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