20 results · 25ms · Sources: EU EUDAMED, US FDA

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DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

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

INCEPTA

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

OT VERIO SYNC METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 3, 2014

FINELINE II

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·April 13, 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

VERSYS FEMORAL STEM

FDA Adverse Event
Injury ·ZIMMER INC·Product code LPH·February 25, 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

ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494

FDA Enforcement
Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

STEM: AMISTEM H HA COATED STD STEM SIZE 5

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

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