22 results · 33ms · Sources: EU EUDAMED, US FDA

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NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General Hospital

HARDYDISK RIFAMPIN, 5MCG

FDA 510(k)
FDA Class 2 ·Microbiology

VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·November 15, 2017

VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·June 22, 2018

AMISTEM H, HA COATED STEM SIZE 2 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 9, 2017

LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 52/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·July 9, 2021

DOUBLE MOBILITY LINER

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·October 15, 2024

LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·May 23, 2019

PIPELINE EMBOLIZATION DEVICE

FDA Adverse Event
Injury ·EV3 NEUROVASCULAR·Product code OUT·April 23, 2013

POWERLOC CLEAR

FDA Adverse Event
Malfunction ·BARD·Product code FPA·April 14, 2011

RIATA ST OPTIM ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

CUP: VERSAFITCUP ACETABULAR SHELL Ø 48

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·March 29, 2023

STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·October 16, 2020

Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

FDA Enforcement
Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

BIOLOX OPTION, HEAD, S, 44/-3.0, TAPER 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code LZO·December 12, 2018

QUADRA S FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·June 6, 2025

VERSAFITCUP DM ACETABULAR SHELL Ø 50

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·October 24, 2015

UNKNOWN

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DTK·June 22, 2016

COOK CELECT FEMORAL VENA CAVA FILTER SET

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·October 19, 2017