19 results · 23ms · Sources: EU EUDAMED, 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