25 results · 27ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

CIMVA UNIVERSAL

FDA 510(k)
FDA Class 2 ·Cardiovascular

Prime Medical LLC

FDA UDI
Prime Medical LLC·00850055249271·PrimePadPlus-K12-3422

MYSPINE MC VERTEBRA L04

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

NUFACE PLUS

FDA 510(k)
FDA Class 2 ·Neurology

LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812

FDA 510(k)
FDA Class 2 ·Neurology

REDUCTION CANNULATED PEDICLE SCREW 5X45

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

INION OTPS BIOABSOBABLE FREEDOMPLATE

FDA Adverse Event
Injury ·INION OY·Product code HRS·November 18, 2014

INION OTPS BIOABSOBABLE FREEDOMPLATE

FDA Adverse Event
Injury ·INION OY·Product code HRS·May 14, 2015

MYSPINE S01 DRILL BASED GUIDE

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

INION OTPS BIOABSORBABLE FREEDOMPLATE

FDA Adverse Event
Injury ·INION OY·Product code HRS·March 19, 2015

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

DIMENSION VISTA 500

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·May 21, 2013

V200 VENTILATOR

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·September 26, 2014

ATTAIN ABILITY

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 14, 2011

UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·May 7, 2012

UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·May 8, 2012

UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·May 7, 2012

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