20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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