11 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
FDA 510(k)
FDA Class 2
·Hematology
LifeFlow Blood System
FDA 510(k)
FDA Class 2
·General Hospital
CERAMIC PEDATRIC PREFORMED CROWN
FDA 510(k)
FDA Class 1
·Dental
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEO·June 19, 2006
METRX
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·March 6, 2013
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 2014
AFFINITY BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code HDD·January 27, 2011
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021