12 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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DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037315033·Ø36 Eccentric Glenosphere with +3mm lateralized...
SSA-770A, APLIO ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DW 277 #4
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 17, 2025
ATRICURE BIPOLAR SYSTEM
FDA Adverse Event
Injury
·ATRICURE, INC.·Product code GEI·July 28, 2010
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 17, 2013
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR SWITZERLAND·Product code FGE·June 19, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 19, 2011
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018