17 results · 23ms · Sources: EU EUDAMED, US FDA

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AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE

FDA 510(k)
FDA Class 2 ·Orthopedic

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973837·

OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770

FDA 510(k)
FDA Class 2 ·Orthopedic

RAPIDO CUT-AWAY CUTTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

BALL HEADS: MECTACER BIOLOX DELTA CERAMIC 12/14 Ø 28 SIZE L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 14, 2021

MPACT DM DOUBLE MOBILITY HC LINER Ø 50/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·July 30, 2019

LINER: MPACT DM DOUBLE MOBILITY HC LINER 22.2/DMC

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·December 7, 2020

FLEXTEND II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code DTB·October 1, 2014

THERMOPHORE AUTOMATIC MOIST HEAT PACK

FDA Adverse Event
Malfunction ·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·February 25, 2013

ASKU

FDA Adverse Event
Injury ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

LINER: MPACT DM DM CONVERTER TIN COATED D/DMB

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 27, 2024

STEM: M-VIZION PROXIMAL BODY Ø20MM L 90MM STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 9, 2024

40" (102 CM) APPX 5.3 ML ADMIN SET W/2 CHEMOLOCK¿

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·June 13, 2025

CUP: MPACT ACETABULAR SHELL Ø56 MULTI-HOLE

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·March 1, 2022

BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 13, 2022

MPACT DOUBLE MOBILITY SHELLS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·February 21, 2024

Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018