14 results
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18ms
·
Sources: EU EUDAMED, US FDA
IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN
FDA 510(k)
FDA Class 2
·Immunology
URIC ACID REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MAGNESIUM B TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536082902·Screw, pre-fixation, Ø 7.5 mm, length 55 mm, no...
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536082865·Screw, pre-fixation, Ø 7.5 mm, length 35 mm, no...
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536082919·Screw, pre-fixation, Ø 7.5 mm, length 60 mm, no...
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536082889·Screw, pre-fixation, Ø 7.5 mm, length 45 mm, no...
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536082896·Screw, pre-fixation, Ø 7.5 mm, length 50 mm, no...
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536082872·Screw, pre-fixation, Ø 7.5 mm, length 40 mm, no...
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 9, 2014
CORMET METAL ON METAL HIP RESURFACING
FDA Adverse Event
Injury
·CORIN LTD·Product code NXT·October 20, 2010
TALENT CAPTIVIA
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·December 21, 2012
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012