9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS]
FDA 510(k)
FDA Class 1
·General Hospital
artegral life
FDA UDI
Merz Dental GmbH·D7091993567·anteriors; shade BL2; mould BS
Galaxy Unyco
FDA UDI
ORTHOFIX SRL·18054242512301·LIMITED TORQUE WRENCH
ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 >=16 ug/mL)
FDA 510(k)
FDA Class 2
·Microbiology
ENTRUST
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·March 7, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·February 16, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 2014
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026