9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900
FDA 510(k)
FDA Class 2
·General Hospital
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503119·Leksell MPS Arc w Counter Scale - ARC ATTACHMEN...
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101932·SS Suture, 1 per sleeve
OPTI-FREE EXPRESS LENS DROPS
FDA 510(k)
FDA Class 2
·Ophthalmic
CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A
FDA 510(k)
FDA Class 2
·Radiology
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 15, 2011
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 15, 2014
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 7, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024