17 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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R-40 EEG Amplifier
FDA 510(k)
FDA Class 2
·Neurology
SimPro™ Now
FDA UDI
Wellspect AB·07392532189081·Single Use Urinary Catheter with water sachet. ...
SimPro™ Now
FDA UDI
Wellspect AB·07333387032795·Single Use Urinary Catheter with water sachet. ...
CoRoent
FDA UDI
Nuvasive, Inc.·00887517402752·CoRoent XLW 15° Base, Ster Tray
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702617641·ELVAREX 2/KNEE HIGH/SLANT-CLOSED TOE-ELEPHANTIA...
ProLift
FDA UDI
Life Spine, Inc.·00190837105655·Static Expandable Cage Trial, 12mm x 28mm x 6mm...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100431·LANCASTER EYE SPECULUM SOLID
Malibu™
FDA UDI
Seaspine Orthopedics Corporation·10889981030155·PRECONTOURED ESS ROD, 5.5 x 600 mm
SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL
FDA 510(k)
FDA Class 2
·Cardiovascular
II Ring Retractor
FDA UDI
Automated Medical Products Corp.·00810118341366·Malleable Retractor 2" x 8" with Protective Edge
MICRO INFILTRATION 3-HOLE SPATULA
FDA UDI
The Wells Johnson Company·B458201516000·Cannula, Micro Infiltration 3-Hole Spatula, on ...
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 7, 2013
PENUMBRA SYSTEM SEPARATOR 032
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 24, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023