905 results · 27ms · Sources: EU EUDAMED, 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