15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BARD ELIMINATOR PET BALLOON DILATORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033936·Baltic Denture System BDLoad BDLoad Mw7 PLSEbi...
PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING
FDA 510(k)
FDA Class 2
·Radiology
SILVERLEAF CONTACT WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
R90 SPACERS
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code MQP·October 9, 2009
R90 SPACERS
FDA Adverse Event
Other
·WARSAW ORTHOPEDIC INC·Product code MAX·November 6, 2009
R90 SPACERS
FDA Adverse Event
Injury
·SOFAMOR DANEK DEGGENDORF GMBH·Product code MAX·December 21, 2009
PORTASCAN
FDA Adverse Event
Malfunction
·MEDIWATCH UK LTD·Product code ITX·November 17, 2011
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·April 3, 2013
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·March 23, 2011
SIGMA HP UNI TIB TRAY SZ2 RMLL
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.·Product code HRY·April 24, 2008
R90 SPACER
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code NKB·August 5, 2011
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018