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

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Leksell Gamma Knife Icon

FDA 510(k)
FDA Class 2 ·Radiology

ProLift Trial

FDA UDI
Life Spine, Inc.·00190837088873·

TX1 TISSUE REMOVAL SYSTEM

FDA 510(k)
FDA Unclassified ·Unknown

ASAHI ANGIOGRAPHIC CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

CUP: VERSAFITCUP CC TRIO 01.26.45.1156 ACETABULAR SHELL CC TRIO NO-HOLE Ø 56

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 16, 2023

ROSA ONE

FDA Adverse Event
Malfunction ·MEDTECH SA·Product code NAY·January 11, 2019

ROSA ONE

FDA Adverse Event
Malfunction ·MEDTECH SA·Product code NAY·January 11, 2019

PINNACLE MTL INS NEUT36IDX50OD

FDA Adverse Event
Injury ·DEPUY INTL., LTD.8010379·Product code KWA·October 8, 2014

VIRTUOSO DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 7, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·June 28, 2011

COCR BALL HEAD 12/14 28 SIZE M 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·July 22, 2020

BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE M 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·July 24, 2020

BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·March 27, 2024

ROSA ONE

FDA Adverse Event
Malfunction ·MEDTECH SA·Product code OLO·March 13, 2019

MASTERLOC FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 23, 2025

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

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 9, 2019

COCR FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·November 18, 2024

TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

FDA Enforcement
Class II ·Terminated·American Optisurgical Inc·June 27, 2012

LINER: MPACT FLAT PE HC LINER 36/E

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·May 25, 2021

CUP: MPACT 3D METAL ACETABULAR SHELL Ø50 TWO-HOLE

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·April 5, 2022