18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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