86 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMARTBUILDER SYSTEM (SB1)
FDA 510(k)
FDA Class 2
·Dental
revogene™
FDA UDI
GenePoc Inc·00628055344001·The revogene™ instrument is intended for in vit...
LoFric® Primo™
FDA UDI
Wellspect AB·07392532135453·Single Use Urinary Catheter LoFric Primo Nelato...
LoFric® Primo™
FDA UDI
Wellspect AB·07333387043074·Single Use Urinary Catheter LoFric Primo Nelato...
MODIFICATION TO HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EMBO PLUS EMBOLECTOMY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SPIROS CLOSED MALE LUER
FDA Adverse Event
Injury
·ICU·Product code FPA·April 11, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 15, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·September 26, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 26, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 11, 2017
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 25, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·April 4, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·April 6, 2017
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 24, 2013
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·September 30, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 7, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·October 3, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 30, 2011