29 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AVS ANCHOR-C CERVICAL CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814695·GENUMEDI SILVER SIZE VI
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814572·GENUMEDI SAND SIZE VI
Pouch Containing Grafted Sensor and Holder, Eversense 365
FDA UDI
SENSEONICS, INCORPORATED·00817491024220·Pouch contains one Eversense 365 Sensor in a Se...
Grafted Eversense 365 Sensor and Holder in Sealed Pouch, Global
FDA UDI
SENSEONICS, INCORPORATED·00817491024589·Pouch contains one Eversense 365 Sensor in a Se...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383556804·Gutta Percha Points is used to root canal filin...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383502764·Gutta Percha Points is used to root canal filin...
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 11, 2019
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837026189·PLATEAU Interbody, Straight, Bulleted, 10mm 26m...
ZAVATION
FDA UDI
Zavation LLC·00842166186767·10mm X 26mm 6° Trial
PLATEAU-TL
FDA UDI
Life Spine, Inc.·00190837028305·PLATEAU-TL Interbody, Convex, Bulleted, 10mm x ...
VATEA ENDONTIC IRRIGATION SYSTEM
FDA 510(k)
FDA Class 1
·Dental
CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNGO SUITE FOR ONCOLOGY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012
HT70 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 1, 2013
PORTEX SPINAL ANESTHESIA TRAYS
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code CAZ·September 12, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·May 20, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 14, 2015
6F Z2 GUIDING CATHETER SR4.0 CATHETER Z26SR40 Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR40
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
FDA Enforcement
Class II
·Terminated·ConvaTec, Inc·March 9, 2016