29 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)
FDA 510(k)
FDA Class 2
·Cardiovascular
R1 shock-proof® black, disinfectable one-piece cuff, adult size, 1-tube
FDA UDI
Rudolf Riester GmbH·04045396178441·Aneroid sphygmomanometers for non invasive meas...
INTERMEDIATE DRILL
FDA UDI
SWEDEN & MARTINA SPA·D7701348783·INTERMEDIATE DRILL SLEEVE 415 D.2.50 L.15.00 MM
INTERMEDIATE DRILL
FDA UDI
SWEDEN & MARTINA SPA·D7701349423·INTERMEDIATE DRILL SLEEVE 415 D.2.50 L.15.00 MM
DRILL
FDA UDI
SWEDEN & MARTINA SPA·D7702694043·DRILL SLEEVE 5.0 D.2.50 L.15.0 MM
MANI NEEDLE & SUTURE PACK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
1717SGN / 1717SCN Digital Flat Panel X-ray Detector
FDA 510(k)
FDA Class 2
·Radiology
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·August 5, 2020
COBE CENTRYSYSTEM 3
FDA Adverse Event
Injury
·GAMBRO HEALTHCARE·Product code FII·July 9, 1998
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·August 12, 2002
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·July 25, 2003
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·April 22, 2019
QUADRA R FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·March 30, 2026
T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·March 22, 2018
PSN DIALYZER (PSN 210)
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORP.·Product code FJI·March 12, 2004
PSN DIALYZER (PSN 210)
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORP.·Product code FJI·March 12, 2004
THUNDERBEAT 5MM, 35CM FRONT ACTUATED GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·November 5, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011
CVC KIT: 3-LUMEN 7 FR (2.3 MM) X 12 (30
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DQY·July 24, 2013
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Enforcement
Class II
·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025