25 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hair Growth System
FDA 510(k)
FDA Class 2
·Physical Medicine
CORTRAK* Enteral Access System
FDA UDI
Avanos Medical, Inc.·00350770456393·Printer Smart Charger
SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5
FDA 510(k)
FDA Class 2
·Radiology
PROLITE PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MERSILENE TAPE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code KDC·November 30, 2018
SYNCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·December 10, 2009
COCR HEAD 28/+4 'L' 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code MEH·January 26, 2026
GRAFTON DBM
FDA Adverse Event
Injury
·OSTEOTECH, INC.·Product code MBP·February 4, 2011
GRAFTON DBM
FDA Adverse Event
Injury
·OSTEOTECH, INC.·Product code MBP·February 4, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
CRANIAL 2.1 BRAINLAB NEURONAVIGATION SOFTWARE
FDA Adverse Event
Malfunction
·BRAINLAB INC·Product code HAW·June 20, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 30, 2011
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·August 29, 2013
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
FDA Enforcement
Class II
·Ongoing·FujiFilm Healthcare Americas Corporation·November 10, 2021
BLAKE DRAIN UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GBX·March 1, 2018
UNKNOWN DEEP BRAIN STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·February 18, 2010
SOLEX® INTRAVASCULAR HEAT EXCHANGE
FDA Adverse Event
Injury
·ZOLL CIRCULATION, INC.·Product code NCX·March 6, 2026
CABLE TENSIONER
FDA Adverse Event
Malfunction
·WRIGHTS LANE : SYNTHES USA PRODUCTS LLC·Product code LXH·December 13, 2017
UNK - NAIL
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·March 28, 2014
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·January 17, 2019