8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ARTICULATED ARM B-SCANNER
FDA 510(k)
FDA Class 2
·Radiology
ERA® 5° DO Small Post Female SS
FDA UDI
STERNGOLD DENTAL LLC·00841549101922·This part contains: 1 female 1.3mm post diamete...
PSYCHEMEDICS RIA CANNABINOID ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EUCLID (TM) TIER 1-GW ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 15, 2014
EXTERNAL PULSE GENERATOR
FDA Adverse Event
Injury
·MEDTRONIC MILACA INC.·Product code DTE·October 31, 2012
4 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·August 17, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021