13 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
FDA 510(k)
FDA Class 2
·Cardiovascular
PEEK Corpectomy
FDA UDI
Nuvasive, Inc.·00887517623997·PEEK Corp Core, Ø14x44mm
YUKON OCT Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
MECHANICAL WHEELCHAIR - L-FRAME SERIES
FDA 510(k)
FDA Class 1
·Physical Medicine
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·April 30, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·December 3, 2025
QC F/K-WIRES Ø0.6-3.2 F/532.001 532.010
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·July 10, 2017
BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 22, 2018
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·October 16, 2025
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·June 25, 2007
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 31, 2014
AKREOS ADAPT ADVANCED OPTICS LENS
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code HQL·January 21, 2011
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98
FDA Enforcement
Class II
·Terminated·Cook Inc.·September 23, 2020