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

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Encore Neutral

FDA 510(k)
FDA Class 2 ·General Hospital

AGXO

FDA UDI
Oticon A/S·05707131305985·H330V2, BTE 13 WL 105 CBE DEMO AGXO

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A162826120·16mm H x 28mm W x 26mm L x 12 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A162826150·16mm H x 28mm W x 26mm L x 15 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A16282680·16mm H x 28mm W x 26mm L x 8 degrees ALIF

AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS

FDA 510(k)
FDA Class 2 ·Radiology

NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011

6000 CMS

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 13, 2013

ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·September 16, 2008

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSD·January 9, 2024

DEKA MOTUS AX

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 25, 2018

EQUINOXE PRESERVE STEM 12MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·May 29, 2019

DEKA MOTUS AX

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·March 9, 2023

SKINTACT

FDA Adverse Event
Injury ·LEONHARD LANG GMBH·Product code GEI·January 25, 2022

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·July 2, 2019

DEKA MOTUS AX

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 6, 2024

EQUINOXE REVERSE 46MM GLENOSPHERE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·October 2, 2024

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022