14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OASYS System
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131282002·H15V2, MINIBTE 312 WL 85 SGR
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100202·NEVYAS DRAPE SPECULUM OPEN WIRE
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962162101·TISCHLER MORGAN BIOPSY PUNCH, 8", SPRING HANDLE...
STRYKER DISCMONITOR
FDA 510(k)
FDA Class 2
·General Hospital
FLIGHT 60 VENTILATOR, MODEL F-60
FDA 510(k)
FDA Class 2
·Anesthesiology
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·January 7, 2016
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 6, 2013
VASOVIEW HEMOPRO
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR·Product code GEI·June 30, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Malfunction
·COOK VASCULAR INC·Product code LJT·January 3, 2019
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Malfunction
·COOK VASCULAR INC·Product code LJT·January 3, 2019
VITAL-PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·May 24, 2016