14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENNOVATE Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138548·Broach, 34 X 28, 13mm Height 17° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138579·Broach, 34 X 28, 19mm Height 17° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138555·Broach, 34 X 28, 15mm Height 17° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138586·Broach, 34 X 28, 21mm Height 17° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138562·Broach, 34 X 28, 17mm Height 17° Hyperlordotic
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
PINN SECTOR W/GRIPTION 54MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·October 10, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 6, 2013
SI AVANTI PLUS
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code DRE·July 14, 2011
C-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 24, 2020
ONE TOUCH ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·August 18, 2009
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024