8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER
FDA 510(k)
FDA Class 1
·Dental
BEHIND THE EAR HEARING AID BERNAFON T-88P
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ISOSTATION KNEE MACHINE (K-100)
FDA 510(k)MINILINK TRANSMITTER
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·June 10, 2014
DEPTH MEASURING GAUGE FOR 2.7MM SCREWS
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·October 7, 2010
PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·December 6, 2012
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
FDA Enforcement
Class I
·Ongoing·Pacific Medical Group Inc.·April 28, 2021
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024