21 results · 22ms · Sources: EU EUDAMED, US FDA

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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