17 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIASORIN LIAISON CMV IGM/IGG
FDA 510(k)
FDA Class 2
·Microbiology
OMNI Knee
FDA UDI
Omni Life Science, Inc.·00841690101925·All Poly 3 Peg Patella 29 mm x 10 mm
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199311·Patella Trial 29mm x 10mm
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981175511·Z-Rod, Dia. 5.5mm, Co-Cr, 290mm
TM "Soloventex" 040-290 S
FDA UDI
REABILITIMED TOV·04823097721148·It is an anti-embolic stockings with an open to...
TM "Soloventex" 040-290 XL
FDA UDI
REABILITIMED TOV·04823097721179·It is an anti-embolic stockings with an open to...
TM "Soloventex" 040-290 L
FDA UDI
REABILITIMED TOV·04823097721162·It is an anti-embolic stockings with an open to...
TM "Soloventex" 040-290 XXL
FDA UDI
REABILITIMED TOV·04823097721186·It is an anti-embolic stockings with an open to...
TM "Soloventex" 040-290 M
FDA UDI
REABILITIMED TOV·04823097721155·It is an anti-embolic stockings with an open to...
LAZERSMILE, LAZERWHITE
FDA 510(k)
FDA Class 1
·Dental
DASH 3000/4000 PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 19, 2025
SYNERGY
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·April 8, 2013
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code HQL·May 8, 2008
VARIOUS HIP PROSTHESES SYSTEMS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 5, 2011
SPINAL ANESTHESIA KIT
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code BSP·November 6, 2018
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013