23 results · 40ms · Sources: EU EUDAMED, US FDA

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OPAL-RAD

FDA 510(k)
FDA Class 2 ·Radiology

PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI

FDA 510(k)
FDA Class 1 ·Ophthalmic

HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

STELLARIS VISION ENHANCEMENT SYSTEM

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·February 5, 2026

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

STELLARIS ELITE VISION ENHANCEMENT SYSTEM

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·March 1, 2022

LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28

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

ARIS TRANS-OBTURATOR SLING

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code OTN·November 6, 2019

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 17, 2013

COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code KRH·June 19, 2008

PRIME 5TH WHEEL STRETCHER, 26"

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·April 11, 2011

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

STELLARIS POWER SUPPLY II

FDA Adverse Event
Malfunction ·BAUSCH + LOMB·Product code HQC·August 1, 2023

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