25 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Swiss LithoClast Trilogy
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
2008T BlueStar Hemodialysis Machine
FDA UDI
Fresenius Medical Care Holdings, Inc.·00840861102082·
Edge™ Diamond ND012-6C Needle
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002509·Diamond dental bur, reusable
NOVO Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331184482·Gerald Bipolar Bayonet Forceps, 7-1/2" (19.0 cm...
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·December 28, 2022
COLIGN
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTHREX MIXING AND DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·July 27, 2022
ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·March 5, 2019
ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·May 1, 2019
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 21, 2014
6000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 14, 2013
TERUMO STERNAL SAW
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GFA·July 19, 2011
BD DIFCO¿ SUPPLEMENT VX WITH RECONSTITUTING FLUID
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·August 22, 2024
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·April 17, 2024
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·May 29, 2024
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·April 29, 2020
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·August 8, 2024
2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·September 18, 2024