12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VICTORY THREE WHEEL SCOOTER, MODEL: SC610
FDA 510(k)
FDA Class 2
·Physical Medicine
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215022679·
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 5, 2021
Crescendo Meniscal Insert CR Standard 13mm Size 5
FDA UDI
AMPLITUDE SAS·03701089524421·
LINEZOLID, 30UG, BBL SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
OLDELFT THORASCAN MODEL NUMBER 180T
FDA 510(k)
FDA Class 2
·Radiology
CANNULATED PARTIALLY THREADED RECONSTRUCTIVE SCREW
FDA Adverse Event
Injury
·BIOMET·Product code HSB·March 13, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 28, 2011
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
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
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