13 results
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26ms
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Sources: EU EUDAMED, US FDA
TRI-CEN GERMICIDAL DETERGENT
FDA 510(k)
FDA Class 1
·General Hospital
BASE
FDA UDI
Nuvasive, Inc.·00887517700599·BASE Ti HL Implant, 10x34x24mm 20°
Gelseal™ Cardiovascular Patch
FDA UDI
VASCUTEK LTD·05037881010434·Gelseal Gelatin Impregnated Knitted Cardiovascu...
PFC SIG RPF CEM FEM SZ 2 LT
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code NJL·April 3, 2020
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295230298·P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM RP...
MBT CEM KEEL TIB TRAY SZ2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NJL·April 3, 2020
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112267·SURG-I-BAND ORANGE
Rampart-T Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
ES-160
FDA 510(k)
FDA Class 2
·Neurology
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 8, 2013
DELTA
FDA Adverse Event
Injury
·HISTORICAL CPI ST. PAUL·Product code DXY·July 22, 2014
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021