19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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InMode Multi-system
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRANSONIC FLOW-QC SET MODEL ADT1010
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TUBECLEAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 3, 2014
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·August 18, 2011
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ? REG. # 8010379·Product code KWA·July 11, 2013
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·June 8, 2021
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·July 14, 2021
V.A.C. GRANUFOAM DRESSING
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC·Product code OMP·June 4, 2021
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·May 22, 2020
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