30 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
36M - City of Gastonia - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588025018·36M - City of Gastonia - Metal
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996132985·LATERAL,TRIAL,6 DEG,22X13
MULITPLE MALE LATX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·March 26, 2025
BARD SOFT MESH
FDA Adverse Event
Injury
·DAVOL INC.·Product code FTL·August 5, 2011
SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE
FDA Adverse Event
Malfunction
·ARTHROCARE CORP·Product code MBI·September 18, 2014
SECURA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·July 2, 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
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·October 21, 2025
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·September 30, 2025
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·September 30, 2025
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