17 results · 21ms · Sources: EU EUDAMED, US FDA

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CAREFUSION NICOLET EDX

FDA 510(k)
FDA Class 2 ·Neurology

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017712·K-Wire, Double Ended, Trocar Point, Diameter Si...

BioCare Safety Needles

FDA UDI
BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K1100520·Caddie, 6.5mm Screws

Lateral Disc Prep

FDA UDI
Life Spine, Inc.·00190837089603·

BEAUTIBOND MULTI PR PLUS

FDA 510(k)
FDA Class 2 ·Dental

MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855

FDA 510(k)
FDA Class 2 ·Neurology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

CASPIAN Spinal System

FDA UDI
VB Spine LLC·10888857242272·Head Adjuster

THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018

VERSACARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·May 2, 2013

CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·June 2, 2011

SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·August 4, 2008

NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021