8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PRESSURE INFUSION DEVICE
FDA 510(k)
FDA Class 1
·General Hospital
DIO CAD/CAM Abutment
FDA 510(k)
FDA Class 2
·Dental
WATCH-PAT 200I (WP200I)
FDA 510(k)
FDA Class 2
·Anesthesiology
ES2 CANNULATED MODULAR TAP
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code LXH·April 30, 2014
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·October 10, 2012
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·April 24, 2015
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025