23 results
·
45ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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