21 results · 21ms · Sources: EU EUDAMED, US FDA

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ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

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

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

VITALITY 2

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 9, 2013

APEXPRO TELEMETRY SYSTEM

FDA Adverse Event
Malfunction ·GE HEALTHCARE·Product code MHX·February 25, 2011

CONTAK RENEWAL 3 RF HE

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 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

25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·March 1, 2016

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

STEM: AMISTEM H HA COATED STD STEM SIZE 5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 5, 2022

OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·June 26, 2024

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012