10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
COLLAGEN NERVE WRAP
FDA 510(k)
FDA Class 2
·Neurology
REMEL
FDA UDI
REMEL, INC.·00848838007163·Gelatin Medium (5ml) 20/PK
SURGISIS GUIDED TISSUE REGENERATION MATRIX
FDA 510(k)
FDA Class 2
·Dental
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 4, 2023
MITEK OMNISPAN MENISCAL REPAIR SYSTEM, W/ 12 DEGREE NEEDLE
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MBI·April 16, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 14, 2011
PEDIPORT 5.5MM SHORT SECONDARY PORT
FDA Adverse Event
Malfunction
·PONCE - USS·Product code GCJ·June 13, 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
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015