12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NEXT GENERATION SALEM SUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503102·Leksell MPS Arc w Counter Scale - ARC AXIS RING...
OMNI Knee
FDA UDI
Omni Life Science, Inc.·00841690101994·All Poly 3 Peg Patella 38 mm x 8 mm
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690110750·Patella Trial 38mm x 8mm
CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SONDREX P.A.L. SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ETAC SWIFT MOBIL
FDA Adverse Event
Malfunction
·ETAC SUPPLY CENTER AB·Product code INM·March 12, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 15, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 7, 2008
DUO FLUID CART WITH SMOKE EVACUATOR
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·July 3, 2019
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
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