7 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
FDA Recall
Completed
·Materialise USA LLC·Product code HWT·July 13, 2022
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
FDA Enforcement
Class II
·Completed·Materialise USA LLC·August 31, 2022
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
FDA Enforcement
Class II
·Completed·Materialise N.V.·August 9, 2023
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
FDA Recall
Completed
·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JEY·June 19, 2023
CarePoint 60 mL Syringe Without Needle, REF: 04-7560
FDA Recall
Completed
·Allison Medical, Inc.·Product code FMF·September 3, 2020
InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC
FDA Recall
Completed
·Allison Medical, Inc.·Product code FMF·January 19, 2018
Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal Catalog Number: 8881560125
FDA Recall
Completed
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code FMF·April 23, 2024