13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aveta System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CETRA
FDA UDI
Orthofix US LLC·18257200120628·3-LEVEL PLATE ASSEMBLY, 72MM
SAFECT MODEL VER 1.0
FDA 510(k)
FDA Class 2
·Radiology
THE WAND MICROACCESS SAFETY INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 23, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 2025
PFC SIGMA CRVD INSERT SZ2 10MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·October 3, 2008
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·June 21, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·August 4, 2011
2008K HEMO. SYS. OLC/DIASAFE PLUS,W/O HP
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code KDI·December 27, 2017
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC and Diasafe; 190304 2008K System w/o OLC and Diasafe and HP; 190452 2008K System w/o OLC and w/ Diasafe Plus; 190303 2008K W/O OLC and DIASAFE W/ HEPARIN PUMP; 190304 2008K W/O OLC and DIASAFE W/O HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KDI·February 20, 2015
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC and Diasafe; 190304 2008K System w/o OLC and Diasafe and HP; 190452 2008K System w/o OLC and w/ Diasafe Plus; 190303 2008K W/O OLC and DIASAFE W/ HEPARIN PUMP; 190304 2008K W/O OLC and DIASAFE W/O HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Holdings, Inc.·May 6, 2015
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024