13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CALCANEAL FRACTURE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707065678·INTRAORAL ELASTICS 2,5 oz 3/8" orange
ACON STREP A RAPID TEST STRIP
FDA 510(k)
FDA Class 1
·Microbiology
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STREP A RAPID TEST STRIP (THROAT SWAB)
FDA Adverse Event
Death
·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code GTY·March 25, 2024
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·December 27, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013
ACETABULAR REAMER 44MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·September 15, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011
UNSPECIFIED BD ALARIS INFUSION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·May 28, 2021
BD ALARIS¿ SECONDARY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 24, 2023
UNSPECIFIED BD ALARIS¿ INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 29, 2022
Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872 Revision H, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010