30 results · 24ms · Sources: EU EUDAMED, 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