9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
THERMAPREP PLUS OVEN
FDA 510(k)
FDA Class 1
·Dental
A.S.A.P.® Dailies Diamond Polishers Marketing Sample
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883006471·A.S.A.P.® Dailies Sample Pack
artegral
FDA UDI
Merz Dental GmbH·D7091970134·anteriors; shade A4; mould ITS
MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098
FDA 510(k)
FDA Class 2
·Anesthesiology
Reperen Surgical Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·April 29, 2014
EDM LUMBAR DRAINAGE KIT OPEN TIP
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·February 15, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·January 11, 2011
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