10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
VESSEL DILATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052023775·Drill chuck adapter 0.7-7.4 mm
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 14, 2024
SYNGO AORTIC VALVEGUIDE SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123
FDA 510(k)
FDA Class 2
·Anesthesiology
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 14, 2024
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 14, 2014
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·January 14, 2013
OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE SMALL
FDA Adverse Event
Injury
·BIOMET UK LTD·Product code NRA·December 2, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024