21 results · 24ms · Sources: EU EUDAMED, US FDA

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RetiCapture

FDA 510(k)
FDA Class 2 ·Ophthalmic

Accent 800 TouchGuide 4 Location

FDA UDI
PRENTKE ROMICH COMPANY·00858526006460·TouchGuides are made from a thin, clear polycar...

MYSPINE MC VERTEBRA L04

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

CAPIOX CIRCUIT CONNECTORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)

FDA 510(k)
FDA Class 2 ·Dental

REDUCTION CANNULATED PEDICLE SCREW 5X45

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

MYSPINE S01 DRILL BASED GUIDE

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

BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·December 6, 2018

MYSPINE-MC DRILL GUIDE L03

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

GEM MICROVASCULAR ANASTOMOTIC COUPLER

FDA Adverse Event
Malfunction ·SYNOVIS SURGICAL INNOVATIONS·Product code MVR·December 28, 2016

MYSPINE STOPPER SLEEVE 30 MM, DRILL2.7 - LUMBAR

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

PLUM XLM W/DATAPORT

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 10, 2014

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FPA·July 23, 2011

ADVANTA BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·June 11, 2013

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

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