21 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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1-CCD ENDOCAM 5520 SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
LIFEPORT VASCULAR ACCESS SYSTEM
FDA Adverse Event
Injury
·HORIZON MEDICAL PRODUCTS, INC.·Product code LJT·March 4, 2002
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973295·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970690·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970676·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970645·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970621·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970638·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970683·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970652·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970669·
CONTOUR
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·April 30, 2010
CONSERVE(R) PLUS CUP
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·March 27, 2013
SWARTZ BRAIDED TRANS. GUIDING INT., 8F, LAMP
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC. (AF-MINNETONKA)·Product code DYB·August 1, 2014
CELL-DYN WBC REAGENT A
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·April 1, 2008
ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 31, 2022
ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 31, 2022
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