14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JAZZ SOLO Sensor
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814275·GENUMEDI PT SILVER R IV
Back-n-Black with Thermo Pocket
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357632244·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A16322480·16mm H x 32mm W x 24mm L x 8 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A163224120·16mm H x 32mm W x 24mm L x 12 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A163224150·16mm H x 32mm W x 24mm L x 15 degrees ALIF
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 15, 2022
GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
FDA 510(k)
FDA Class 2
·Microbiology
HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING
FDA 510(k)
FDA Class 2
·General Hospital
FREESTYLE LITE
FDA Adverse Event
Injury
·Product code NBW·July 27, 2011
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·July 8, 2011
PROLIFT +M PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·June 11, 2013
*
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 8, 2008
4.5 BROAD SCP PLT 26-H STER
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017