23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT
FDA 510(k)
FDA Class 2
·Dental
TEAR LIGHT TAPE
FDA UDI
Mueller Sports Medicine, Inc.·00074676136820·TEAR LIGHT TAPE PINK 2" X 7.5YD 24 ROLLS
LINK Instruments - Chisel, bone curette, raspatory, rongeur
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575033348·Orthopaedic prosthesis instrument, reusable - G...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450412572·
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3
FDA 510(k)
FDA Class 2
·Dental
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 22, 2021
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 16, 2021
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 29, 2021
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 24, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 30, 2014
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·June 10, 2011
CONTOUR NEXT
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 22, 2021
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 27, 2020
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 9, 2021
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 2, 2021
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code DYB·May 5, 2016
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 15, 2019
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·June 15, 2016