184 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
32mm Glenosphere and Humeral Cup
FDA UDI
FX SOLUTIONS·03701037314302·GLENOID RESURFACING REAMER Ø32mm WITH DRILL/HUDSON
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0600070·Tray Insert, 1.5" Blank
Intess C
FDA UDI
Kalitec Direct LLC·B07309K0100270·Assembly, Caddie, Large Cervical Implants, Hinged
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100270·Tray Insert Iliac Screws 12 x 12 Assembly
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·BO73DRK0100270·Rasp, Angled Lumbar
MAXIM KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INSUFFLATION NEEDLE, MODEL R65-933
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PARADYM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code NIK·November 18, 2014
PARADYM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code NIK·January 31, 2014
PARADYM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code NIK·January 31, 2014
PARADYM
FDA Adverse Event
Malfunction
·SORIN BIOMEDICA C.R.M., S.R.L.·Product code NIK·October 1, 2010
PARADYM
FDA Adverse Event
Malfunction
·SORIN C.R.M., S.R.L.·Product code NIK·November 30, 2012
PARADYM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L·Product code NVZ·November 22, 2013
PARADYM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code NIK·December 20, 2013
PARADYM
FDA Adverse Event
Malfunction
·SORIN CRM S.R.L.·Product code MRM·March 9, 2012
PARADYM
FDA Adverse Event
Death
·SORIN GROUP ITALIA S.R.L.·Product code NIK·October 31, 2013
PARADYM
FDA Adverse Event
Malfunction
·SORIN CRM S.R.L.·Product code NIK·March 6, 2013
PARADYM
FDA Adverse Event
Malfunction
·SORIN BIOMEDICA CRM S.R.L.·Product code NIK·December 7, 2009
PARADYM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code NIK·August 30, 2013