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

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BreathID Hp System

FDA 510(k)
FDA Class 1 ·Microbiology

MYSPINE MC VERTEBRA L04

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·July 6, 2018

VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE)

FDA 510(k)
FDA Class 1 ·General Hospital

HPR EMOLLIENT FOAM

FDA 510(k)
FDA Unclassified ·Unknown

REDUCTION CANNULATED PEDICLE SCREW 5X45

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·February 17, 2023

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 9, 2019

MYSPINE S01 DRILL BASED GUIDE

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·December 12, 2018

MYSPINE-MC DRILL GUIDE L03

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PQC·May 26, 2023

MYSPINE STOPPER SLEEVE 30 MM, DRILL2.7 - LUMBAR

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LXH·February 26, 2020

ANIMAS INSULIN INFUSION PUMP

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

VITALITY

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 24, 2011

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 15, 2014

M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·July 16, 2025

MYSPINE UNILATERAL LEFT GUIDE S01

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024

ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·January 10, 2024

M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2024

MYSPINE MYSPINE MC DRILL BASED GUIDE L04

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PQC·February 14, 2020

BD INTIMA-II Y 22GAX1.00IN PRN/PRN SLM NPVC

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·January 9, 2025

Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022