22 results · 29ms · Sources: EU EUDAMED, US FDA

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QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00

FDA 510(k)
FDA Class 2 ·Radiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526189768·*USE K011231*LEVAMED ACTIVE ANKL SUP BL

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033513279·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033513316·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033513262·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033513286·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033513293·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033513309·

ILT DEFLECTING CATHETER, MODEL C114ND1

FDA 510(k)
FDA Class 2 ·Cardiovascular

CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER

FDA 510(k)
FDA Class 2 ·Orthopedic

WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

FDA Adverse Event
Death ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·May 21, 2025

WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·May 21, 2025

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 20, 2013

STRATA 2, ADJUSTABLE VALVE, REGULAR

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·February 3, 2011

INSYNC II MARQUIS

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code NIK·March 10, 2008

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 2, 2016

ARROW PICC COMPONENT: 3 FR X 21-1/2" (55 CM)

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC.·Product code LJS·December 4, 2020

INDIGO SYSTEM ASPIRATION CATHETER 6

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code DXE·July 12, 2019

ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPT

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·November 15, 2023

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015