31 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PREMIUM ONE Implant Systems
FDA 510(k)
FDA Class 2
·Dental
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169596177·TRIAL 2172560 O25 IB 20MM 12 DEG 16X60
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704511161·
Epredia
FDA UDI
SHANDON DIAGNOSTICS LIMITED·05051663517737·CTM6 coverslipper- Accessory
Sklar®
FDA UDI
SKLAR CORPORATION·10649111334214·SPENCER WELLS FCP STR 6"
Lacrimal Probe
FDA UDI
KATENA PRODUCTS, INC.·00841668108796·BOWMAN LACRIMAL PROBE #7-8
REPROCESSED PULSE OXIMETER SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·October 30, 2018
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·April 3, 2020
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013
ENDURANT EXTENSION CUFF STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 20, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 2008
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·August 26, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·September 26, 2018
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·February 4, 2020
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·July 9, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·July 3, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·October 12, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·August 7, 2019