53 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7
FDA 510(k)
FDA Class 2
·General Hospital
Altus Spine Cervical Interbody Fusion System
FDA UDI
Altus Spine, LLC·00843210131016·ALR Inserter
OsteoMed
FDA UDI
OSTEOMED LLC·00845694001199·23mm Left L Plate
SAVANNAH
FDA UDI
SPINAL ELEMENTS·00840916151294·SAVANNAH®-T PERSUADER
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193107899·HA PEEK EVOS Straight, ,16mmx8mmx 22mm , FLAT ...
Preat
FDA UDI
Preat Corporation·00842092186213·PreatLoc™ Extended Pivot Processing Pack Assem...
Preat
FDA UDI
Preat Corporation·00842092186206·PreatLoc™ Extended Pivot Processing Pack Assem...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694029551·23mm Left "L" Plate, Sterile
Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016, 100018 -100025 The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 14, 2010
OsteoMed
FDA UDI
OSTEOMED LLC·00845694063043·2.0 System 4 Hole 23mm Left L Plate Sterile Qty 5
BARCOMED 5MP2
FDA 510(k)
FDA Class 2
·Radiology
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL
NEONATAL BUBBLE CPAP DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·Product code BZE·March 3, 2021
OSTEOMED STRAIGHT PLATES, "L" PLATES, "Y" PLATES
FDA Adverse Event
Injury
·Product code HRS·August 8, 2013
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CT LUCIA Intraocular Lens (IOL)
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CT LUCIA 621P
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CT LUCIA Intraocular lens (Model 611P)
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Zeiss 3-piece Hydrophobic Acrylic Intraocular lens (IOL)
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CT LUCIA 602, CT LUCIA 202