13 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MONITOR, PATIENT (MODEL 78331A)
FDA 510(k)
FDA Class 2
·Cardiovascular
Bioseal Inc.
FDA UDI
BIOSEAL·00630094176017·Connector 5 in 1
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110546·QUICK SWITCH IRRIGAT-ASPIRAT HAND PIECE
Centronail Titanium Supracondylar Nailing System
FDA UDI
ORTHOFIX SRL·18032937162024·CENTRONAIL TITANIUM SUPRACONDYLAR NAIL D.10 MM-...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110638·COAXIAL IRR-ASP TIP STR W/SILICONE 0.3MM
INSTANT-VIEW FOB Test - complete kit, 50 test
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·30796918001901·INSTANT-VIEW FOB Test
Fecal Occult Blood – Cass...
Inertia® CONNEXX™ Modular Pedicle Screw System
FDA UDI
NEXXT SPINE, LLC·00889929046906·Straight Rod, Ø6.0x150 mm
Vitrea CT Colon Analysis
FDA 510(k)
FDA Class 2
·Radiology
SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
DIMENSION XPAND PLUS WITH HM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·April 18, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·September 20, 2012
EYE SURGERY STRETCHER
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FPO·July 12, 2010
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025