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

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PALOMAR ICON (TM) AESTHETIC SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Luxatemp® Ultra

FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1109070·Temporary crown and bridge material automix sys...

TALOS®-C HA

FDA UDI
MEDITECH SPINE, LLC·B167521109070·

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K1100070·Tray Insert 1, NIDO

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964084744·Endo Carry-On Procedure Kit

HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL

FDA 510(k)
FDA Class 1 ·General Hospital

TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 120

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·January 8, 2013

NON-HEATED ADULT BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·December 16, 2012

ADULT BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 20, 2011

ESTEEM

FDA Adverse Event
Malfunction ·ENVOY MEDICAL CORPORATION·Product code OAF·March 9, 2022

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·May 8, 2013

VASOVIEW HEMOPRO EVH SYSTEM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·February 15, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·November 26, 2018

VENTED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 27, 2014

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025