12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Atlantis Abutment for MIS Implant
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814220·GENUMEDI PT SILVER L V
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331171819·tissue forceps, standard pattern, serrated hand...
AOS HUMERAL NAIL 8.0mm x 22.5cm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016901·
ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST
FDA 510(k)
FDA Class 1
·Clinical Toxicology
ANGIOSCULPT PTA SCORING BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 3, 2025
PENUMBRA COIL 400
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code HCG·November 29, 2016
ETHICON
FDA Adverse Event
Injury
·JOHNSON & JOHNSON / ETHICON·Product code FTL·July 14, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 5, 2013
COBAS INTEGRA 400 PLUS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·September 19, 2008
CP5 FLOW MODULE
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWA·July 18, 2024