11 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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NEXGEN PROLONG ALL-POLY PATELLA
FDA 510(k)
FDA Class 2
·Orthopedic
Tru-Chrome
FDA UDI
Rmo, Inc.·00885797016966·TRU-CHROME NAT ARCH MN .017 X .025
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215022143·
Crescendo Meniscal Insert CR Ultracongruent 17mm Size 1
FDA UDI
AMPLITUDE SAS·03701089524940·
TRS-2000 POWER TILT/POWER RECLINE SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
STELKAST PROVEN KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DRIVE MEDICAL
FDA Adverse Event
Injury
·HL CORP (SHENZHEN)·Product code IPS·April 19, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 28, 2011
SPRINT QUATTRO SECURE
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