20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Duo Lumbar Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813019122·GLOVES PF LATEX HANDS ON SM DARBY
CoRoent
FDA UDI
Nuvasive, Inc.·00887517638960·CoRoent Ant TLIF PEEK, 8x12x32mm 12°
Mouse anti-MUC4 (1G8) Concentrate
FDA UDI
LIFE TECHNOLOGIES CORPORATION·10190302008099·
STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)
FDA 510(k)
FDA Class 2
·Orthopedic
AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
MOBILELINK ACETABULAR CUP SYSTEM
FDA Adverse Event
Malfunction
·WALDEMAR LINK GMBH & CO. KG·Product code LPH·February 20, 2025
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 1, 2023
EKOSONIC KIT 106CM 12CM TZ
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 14, 2021
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 10, 2013
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·July 11, 2011
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·September 30, 2008
EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 3, 2022
EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·July 30, 2021
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023
BD PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 23, 2021
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026