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

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EchoPAC Software Only, EchoPAC Plug-in

FDA 510(k)
FDA Class 2 ·Radiology

TRIAL CABLE, 3009

FDA 510(k)
FDA Class 2 ·Neurology

SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30

FDA 510(k)
FDA Class 2 ·Radiology

COMFORT TOUCH INSUIN PEN NEEDLES

FDA Adverse Event
Malfunction ·JIANGSU CAINA TECHNOLOGY CO., LTD.·Product code FMI·May 21, 2021

MINIMAX STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 24, 2025

MINIMAX RIGHT ANATOMICAL BROACH SIZE 2

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LXH·February 20, 2020

MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 6, 2019

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 14, 2014

V-PRO STERILIZER

FDA Adverse Event
STERIS MEXICO, S. DE R.L. DE C.V.·Product code MLR·June 14, 2013

ACCU-CHEK SPIRIT CARTRIDGE

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·June 22, 2011

MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2017

LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·April 4, 2019

CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 4, 2019

CUP: VERSAFITCUP ACETABULAR SHELL Ø 48

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·December 27, 2019

CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 8, 2021

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024