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

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Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid

FDA 510(k)
FDA Class 2 ·Orthopedic

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138272·Trial, 42 X 32, 19mm Height 28° Hyperlordotic

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138289·Trial, 42 X 32, 21mm Height 28° Hyperlordotic

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138265·Trial, 42 X 32, 17mm Height 28° Hyperlordotic

URYXXON RELAX URINE ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DOUBLE MOBILITY HC LINER 28/DMD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·December 2, 2016

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE 1

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 12, 2019

PROTECTA CRT-D

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 10, 2014

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code LZG·July 8, 2011

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·January 4, 2017

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021