13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PERI-PATCH PERITONEAL CATHETER EXTENSION
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317350169·
Ovation® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K310531101·OVATION® C Base Rx 018 U5-5/L3-3 CS HK
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531101·MYSTIQUE® MB RT RX 018 U5-5/L3-3 CS HK
Ovation® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K310531111·OVATION® C RT RX 018 U5-5/L3-3 CS BC HK
Ovation® C EURO
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K310531801·OVATION® C EURO 018 U5-5/L3-3 CS HK
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531111·MYSTIQUE® MB RT RX 018 U 5-5/L3-3 CS-BC HK
ILT DEFLECTING CATHETER, MODEL C114ND1
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOFLIP ECD
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL- NEUROMODULATION·Product code GZF·May 6, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 21, 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