8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Puritan PurSafe Plus Collection and Transport System
FDA 510(k)
FDA Class 2
·Microbiology
BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear
FDA 510(k)
FDA Class 2
·Ophthalmic
SYSTEMP.C&B PLUS
FDA 510(k)
FDA Class 2
·Dental
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 19, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026