14 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756370851·CVOR ECMO PACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112274·SURG-I-BAND WHITE
Symmetry Roeder
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482130353·Symmetry® Applicator; Roeder Loop; 5 mm; 6 7/8 in
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
KENSTONE METAL·Product code ITJ·July 20, 2012
Zavation
FDA UDI
Zavation LLC·00842166182400·Sizer, Round
F10
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Y-TZP POWDER AND PROCERA ALLZIRKON
FDA 510(k)
FDA Class 2
·Dental
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962152133·ROEDER LOOP APPLICATOR, 5MM
MULTI SPECT 2 [510(K) K913630]
FDA Adverse Event
Other
·SIEMENS MEDICAL SYSTEMS·Product code IYX·April 13, 2001
EPIDURAL CATHETERIZATION KIT
FDA Adverse Event
Injury
·ARROW INTERNATIONAL INC·Product code CAZ·November 19, 2010
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·July 2, 2014
LIGASURE IMPACT THORACIC
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·December 4, 2012
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020