9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BONDING BASE
FDA 510(k)
FDA Class 2
·Dental
ALIF
FDA UDI
Nuvasive, Inc.·00887517972699·ALIF Blade, 100mm Wide
DO-ALL DENTAL HANDPIECE LUBRICANT
FDA 510(k)
FDA Class 1
·Dental
VASCULAR GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
TRANSPORT 20 IN X 16 IN 9153637574
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·August 5, 2015
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 21, 2013
INSIGNIA
FDA Adverse Event
Death
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·August 1, 2014
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014
FDA Enforcement
Class I
·Ongoing·ICU Medical, Inc.·October 29, 2025
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FMG·October 2, 2025