27 results · 23ms · Sources: EU EUDAMED, US FDA

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MODULAR FOOT SYSTEM - 2.7 MM MODULE

FDA 510(k)
FDA Class 2 ·Orthopedic

Zirlux

FDA UDI
HENRY SCHEIN, INC.·H65890103210·Zirlux UCLA Plastic Abut Eng

Soft-Form™ ALD External Nasal Splint

FDA UDI
INVOTEC INTERNATIONAL, INC.·00818501022557·Soft-Form™ ALD External Nasal Splint, Large

Oxygen Sensor

FDA UDI
MERCURY ENTERPRISES, INC.·10641043103210·

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0100210·SNII Awl Tap, 5.50mm

Matira

FDA UDI
Kalitec Direct LLC·B07307K0100210·Assembly, Caddie, Plates and Screws, Hinged

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0100210·Caddie Lid, Rods, 5.5mm

HEMISPHERE MODULAR CUP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ALL-PRO 2010

FDA 510(k)
FDA Class 2 ·Radiology

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 18, 2025

AUTOSOFT XC

FDA Adverse Event
Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 30, 2025

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·October 27, 2025

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·October 27, 2025

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·October 27, 2025

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 12, 2025

XPS® BUR GUARD - VISAO®

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code ERL·April 22, 2016

FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 19, 2013

LIFEVEST WCD 3000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 11, 2011

XPS® BUR

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·March 13, 2017