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

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GALILEO Spine Alignment Monitoring System

FDA 510(k)
FDA Class 2 ·Neurology

PROPELLER HEAD SCREW SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304270282·

MiniSPC Button

FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071148164·18F x 2.5cm MiniSPC Low Profile Suprapubic Cath...

MiniSPC Button

FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071150785·18F x 2.5cm MiniSPC Low Profile Suprapubic Cath...

BD RODAC¿ SNAP LID TRYPTICASE¿ SOY AGAR (TSA) W LECITHIN & POLYSORBATE 80

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·December 7, 2022

MINI GHOST, MODEL: 507

FDA 510(k)
FDA Class 2 ·Cardiovascular

FUTURA

FDA 510(k)
FDA Class 2 ·Physical Medicine

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 19, 2011

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 14, 2013

*

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·July 21, 2008

VANGUARD ROCC POR FEM S60 L

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code JWH·February 3, 2026

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Injury ·COOK INC·Product code FGE·April 25, 2019

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Injury ·COOK INC·Product code FGE·January 4, 2019

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Injury ·COOK INC·Product code FGE·February 18, 2019

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·July 26, 2019

VANGUARD MONO FINNED STM TIB 71X8

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code JWH·August 9, 2023

VANGUARD ROCC POR FEM S60 L

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code JWH·February 20, 2025

Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

FDA Enforcement
Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023