9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURGIMEND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
R&D RET-LINE KIT
FDA 510(k)
FDA Class 2
·Hematology
BD INSYTE AUTOG BC PNK
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 13, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 11, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 28, 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
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