13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
JAZZ SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131257901·H16, MINIBTE 312 WL 85 TC
MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·April 19, 2023
INFLATOR KIT 18INFKIT BALLOON
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014
BALLOON SEEKER
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014
12/14 ARTICUL 40MM M SPEC-2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·May 29, 2013
ESSX HANDPIECE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·June 11, 2011
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·August 22, 2008
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
FDA Enforcement
Class II
·Terminated·Zimmer Dental Inc·February 5, 2014
IPSOGEN JAK2 PCR KIT IVD
FDA Adverse Event
QIAGEN GMBH·Product code PSU·September 4, 2018
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
FDA Recall
Terminated
·Zimmer Dental Inc·Product code DZE·January 6, 2014