39 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ReWalk P6.0
FDA 510(k)
FDA Class 2
·Physical Medicine
ReLine
FDA UDI
Nuvasive, Inc.·00195377047151·RELINE-O Trial,12mm H Lamina Ang W L-pop
ELMED
FDA UDI
ELMED INCORPORATED·00842180157583·STOPCOCK WITH MALE LUER LOCK & 6 MM DIAMETER BA...
REYNOLDS STEVENS TENOTOMY SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083523·REYNOLDS STEVENS TENOTOMY SCISSORS CURVED BLADE...
VASER
FDA UDI
SOLTA MEDICAL·00816995027423·FOOTSWITCH, GEM
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613123406·Stopcock, With Male Luer Lock, 6mm Diameter Bar...
POTTS SMITH FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896094000·POTTS SMITH FORCEPS TUNGSTEN CARBIDE DUST TIP
Transcatheter Septal Occluder (Atrial)
FDA Pre-Market Approval
FDA Class 3
·Occlutech® ASD Occluder and Occlutech® Pistol Pusher
APEX MEDICAL MINI TENS
FDA 510(k)
FDA Class 2
·Neurology
LEVEEN NEEDLE ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Transcatheter Septal Occluder (Atrial)
FDA Pre-Market Approval
FDA Class 3
·Occlutech Pistol Pusher
Transcatheter Septal Occluder (Atrial)
FDA Pre-Market Approval
FDA Class 3
·Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack
Transcatheter Septal Occluder (Atrial)
FDA Pre-Market Approval
FDA Class 3
·Occlutech® ASD Occluder and Occlutech® Pistol Pusher
Transcatheter Septal Occluder (Atrial)
FDA Pre-Market Approval
FDA Class 3
·Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack
Transcatheter Septal Occluder (Atrial)
FDA Pre-Market Approval
FDA Class 3
·Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack
Transcatheter Septal Occluder (Atrial)
FDA Pre-Market Approval
FDA Class 3
·Occlutech® ASD Occluder and Occlutech® Pistol Pusher
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 9, 2015
ELITE RISER
FDA Adverse Event
Injury
·NOA MEDICAL INDUSTRIES INC·Product code FNL·March 20, 2012
IVENIX LARGE VOLUME INFUSION PUMP
FDA Adverse Event
Malfunction
·FRESENIUS KABI USA, LLC·Product code FRN·May 23, 2024
NEOTRACT UROLIFT SYSTEM UL400
FDA Adverse Event
Injury
·NEOTRACT, INC.·Product code PEW·February 24, 2015