16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMBOGUARD Balloon Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517569301·CoRoent Ant TLIF Ti, 11x12x34mm 0°
Deltec
FDA UDI
ICU MEDICAL, INC.·10610586025129·
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78821234000301·EXPERIENCE Mini XT 022/LL4&5-7T-1A 2D
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78821234000201·EXPERIENCE Mini MBT 022/LL4-12T 2A
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78821234000101·EXPERIENCE Mini ROTH 022/LL4-17T-1A 4D
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730007674·Votion 018 MC(0T) UL3 0T 8A 0O (10PK)
Votion®
FDA UDI
Ortho Organizers, Inc.·00190707113360·Votion .018 MC(0T) UL3 0T 8A 0O (10PK) VOTION
BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRODIGY CHOICE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿), PLATE, 90 MM X 120
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSO·March 29, 2022
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·August 15, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·July 9, 2013
9 Fr Introducer Set, REF 21-2340-24
FDA Recall
Terminated
·Deltec, Inc·Product code DYB·March 29, 2004
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026