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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BELMONT QUOLIS 5000 SERIES DENTAL UNIT
FDA 510(k)
FDA Class 1
·Dental
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215022099·
Crescendo Meniscal Insert CR Ultracongruent 15mm Size 3
FDA UDI
AMPLITUDE SAS·03701089524896·
STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·March 25, 2021
STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE
FDA 510(k)
FDA Class 2
·Cardiovascular
SPIRAL RADIUS 90-D SST SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RENAL UROLOGY STENT K072293
FDA Adverse Event
Other
·FOSSA MEDICAL INC·Product code FAD·April 10, 2014
AFFINITY BIRTHING BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·April 4, 2013
PCA II PUMP
FDA Adverse Event
Death
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 28, 2011
TRANSVENE
FDA Adverse Event
Injury
·MEDTRONIC, 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