16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
APTUS Wrist 2.5 System
FDA 510(k)
FDA Class 2
·Orthopedic
Equator
FDA UDI
Preat Corporation·00842092182192·Equator Abutment for Astra EV 5.4 x 6mm
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025
AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101
FDA 510(k)
FDA Class 2
·General Hospital
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025
SMITHS MEDICAL HYPODERMIC NEEDLE-PRO REF 4290
FDA Adverse Event
SMITHS MEDICAL ASD, INC.·Product code FMI·June 23, 2022
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025
CS300
FDA Adverse Event
Death
·DATASCOPE CORP.·Product code DSP·May 30, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 12, 2014
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 23, 2011
ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVE·June 13, 2025
BACTEC LYTIC/10 ANAEROBIC/F MEDIUM
FDA Adverse Event
Injury
·BD DIAGNOSTIC SYSTEMS·Product code MDB·January 29, 2015
Cobe CML Duo Flat Sheet Membrane Oxygenator, Non-sterile, Catalog Number: 436122974, COBE Cardiovascular, Inc..-(shipped international only for use in Heart/Lung Packs)
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006
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