31 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Bone Cement
FDA Pre-Market Approval
FDA Class 2
·OMNIPLASTIC BONE CEMENT
Ivostar Gnathostar
FDA UDI
IVOCLAR VIVADENT AKTIENGESELLSCHAFT·DIVO5171131·Gnathostar Set of 8 UD88 6C
Leva™ Spacer System
FDA UDI
Spine Wave, Inc.·10840642100341·Fixed Implant 25mm x 10mm x 13mm
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837047184·ALIF Controlled Deployment Device
Novaclips
FDA UDI
VITALITEC INTERNATIONAL, INC.·00852621004031·Vascular Clamp
TriVerse Meniscal Insert AS
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215101442·
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 25, 2013
2124215-2012-17113
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code LWS·January 14, 2013
3005075853-2019-17113
FDA Adverse Event
Malfunction
·March 8, 2019
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 18, 2008
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 16, 2024
THINWALLED FEP RINGED GORE-TEX VASCULAR GRAFT
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES, INC.·Product code DSY·November 19, 2007
THINWALLED FEP RINGED GORE-TEX VASCULAR GRAFT
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES, INC.·Product code DSY·November 16, 2007
ANGIO-SEAL
FDA Adverse Event
Injury
·THE KENDALL CO.·Product code MGB·April 5, 1999
THERMOPHORE
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT CO.·Product code IRT·August 28, 1997
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·February 16, 2001
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·October 12, 2022
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·November 8, 2016
LTV 1200 VENTILATOR
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL INC.·Product code CBK·September 19, 2022
ONE TOUCH ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·July 27, 2009