10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).
FDA 510(k)
FDA Class 2
·Dental
COPELAND RESURFACING HUMERAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 18, 2020
SEE H10 NARRATIVE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·September 11, 2017
UNKNOWN LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015
CD HORIZON
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·April 22, 2013
FLOSEAL HEMOSTATIC MATRIX
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - HAYWARD·Product code LMF·April 27, 2011
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·July 1, 2008
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016