21 results
·
22ms
·
Sources: EU EUDAMED, US FDA
BostonSight® Specialty Lenses
FDA 510(k)
FDA Class 2
·Ophthalmic
ACTIV.A.C. Negative Pressure Wound Therapy System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PEN NEEDLE AUTOSHIELD DUO 30GX5MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·August 12, 2019
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2014
LIGASURE ADVANCE PISTOL GRIP
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·September 2, 2011
CONSERVE(R) PLUS HA CUP
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·July 22, 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
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014