213 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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ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN
FDA 510(k)
FDA Class 2
·General Hospital
Bernafon
FDA UDI
Bernafon AG·05711584051009·CA3 ITCD, WL L BE CARISTA 3
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE
FDA 510(k)
FDA Class 2
·Microbiology
WATCH-PAT 200S-3 (WP200S-3)
FDA 510(k)
FDA Class 2
·Anesthesiology
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 1, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 10, 2011
BD PHOENIX¿ NMIC-311
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026
BD PHOENIX¿ NMIC-311
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 28, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 14, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·May 27, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 20, 2026
ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Skeletal Kinetics, Llc·July 22, 2020
AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·October 30, 2018
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·April 3, 2020
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·August 26, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·September 26, 2018