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

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MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

JTS EXTENDEABLE IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

Rejuvapen NXT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

JTS UNIT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·September 11, 2018

JTS COIL

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·February 13, 2020

JTS DRIVE UNIT SET

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·March 6, 2023

VERSAPORT

FDA Adverse Event
Malfunction ·COVIDIEN FORMERLY FORMERLY KENDALL A DIVISION OF TYCO HEALTHCARE·Product code GCJ·February 28, 2013

INTEGRATED APD SET W/CASSETTE3 PRONG

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 15, 2011

CAPSUREFIX MRI SURESCAN

FDA Adverse Event
Injury ·MPRI·Product code NVN·August 8, 2014

JTS DRIVE UNIT SET

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·March 15, 2022

PROXIMAL TIBIA JTS (DISTAL FEMORAL COMPONENT)

FDA Adverse Event
Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 28, 2018

JTS DRIVE UNIT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 21, 2019

JTS DRIVE UNIT SET

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·May 27, 2022

JTS EXTENDIBLE DISTAL FEMORAL IMPLANT

FDA Adverse Event
Injury ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·July 24, 2014

JTS DRIVE UNIT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·April 8, 2020

JTS DRIVE UNIT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·June 29, 2020

CUSTOM PROXIMAL FEMUR JTS REPLACEMENT IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·June 25, 2015

DISTAL FEMUR JTS

FDA Adverse Event
Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·July 18, 2019

JTS DRIVE UNIT SET

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·April 28, 2022

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022