905 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2
FDA 510(k)
FDA Class 2
·Hematology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112700·BARRON VACUUM PUNCH 6.0MM
LEONE SPA
FDA UDI
LEONE SPA·08033707036975·DB BRACKETS 22 MOLAR
Histofluor® IgA Fluorescent Antibody Test System
FDA UDI
IMMUNO CONCEPTS INC·M749120210111·Histofluor® EMA Positive Control 1 x 1.0 ml
MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR
FDA 510(k)
FDA Class 1
·General Hospital
ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 8, 2021
PUMP MMT-1782K 670G V4.11 MM
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 24, 2021
PUMP MMT-1712KL 640G V4.10 BK SF MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 8, 2022
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 8, 2021
RADIAL JAW 3 BIOPSY FORCEPS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCL·October 16, 2008
WALRUS EMBOLECTOMY CATHETER COMPONENT
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DXE·June 27, 2013
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011
PUMP MMT-1782KL 670G MM RPL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 15, 2021
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 8, 2021
INJECTOR N35-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FPA·January 7, 2021
640G INSULIN PUMP MMT-1712K
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 9, 2021
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 21, 2022
BD BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·July 8, 2021
INSORB 30 STAPLER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GAG·December 13, 2020