23 results · 45ms · Sources: EU EUDAMED, US FDA

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EQUIMATRIX

FDA 510(k)
FDA Class 2 ·Dental

Flexitron

FDA UDI
Nucletron B.V.·08717213022331·Flexitron Transfer Tube Set for Metal Needles (...

TALOS® HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321118160·

MINI MULTILEAF COLLIMATOR, MODEL KMI

FDA 510(k)
FDA Class 2 ·Radiology

STN PROBE

FDA 510(k)
FDA Class 2 ·Radiology

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 24, 2025

Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

FDA Recall
Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

FDA Enforcement
Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 17, 2021

STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 19, 2022

INFINITI VISION SYSTEM OZIL

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 7, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 26, 2011

POLYFLUX LR CAPILLARY DIALYZER

FDA Adverse Event
Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·August 14, 2008

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2025

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 27, 2025

M-VIZION PROXIMAL BODY HANDLE

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·March 28, 2024

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·May 28, 2026

STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 24, 2021

M-VIZION INSERTER ROD

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·May 28, 2024

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 16, 2025