24 results
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23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex Vortex Threaded Bone Marrow Recovery Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526799363·MANUMED ACTIVE WRIST RIGHT SILVER M
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114179·KRATZ POLISHER 23GA SIDE (PK/10)
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132130·Trial, TLIF, 27L OB CRV 7Deg, 13mm
HEARTWARE® VENTRICULAR ASSIST SYSTEM-CONTROLLER2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·September 14, 2017
HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·October 25, 2019
HYPERION VISIQUANT ANA TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
FDA 510(k)
FDA Class 2
·Cardiovascular
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 1, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 1, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 1, 2023
IAB: 7.5FR - 40 CC
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DSP·July 28, 2014
HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·June 5, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
BD PHASEAL¿ INJECTOR LUER LOCK N35C
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONG·December 1, 2017
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·August 4, 2014
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
RF3000 RADIOFREQUENCY GENERATOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEI·July 9, 2013
HEARTWARE® VENTRICULAR ASSIST SYSTEM-CONTROLLER 2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·August 29, 2017
BD PHASEAL¿ CONNECTOR LUER LOCK (C35)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 13, 2019