26 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VIVORTE BVF
FDA 510(k)
FDA Class 2
·Orthopedic
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037301357·HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +3
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037303504·TRIAL HUMERAL CUP 135/145° STANDARD Ø36 +3
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037313992·STANDARD TRIAL HUMERAL CUP CUSTOM MADE 135/145°...
Trabexus®
FDA UDI
Vivorte, Inc·W4146EB0010T0475·Calcium compound bone void filler with DBM (10 ...
Trabexus®
FDA UDI
Vivorte, Inc·W4146EB0003T0475·Calcium compound bone void filler with DBM (3 c...
Trabexus®
FDA UDI
Vivorte, Inc·W4146EB0005T0475·Calcium compound bone void filler with DBM (5cc...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857560840·Forward Angled Curette Size #2
STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS
FDA 510(k)
FDA Class 2
·Radiology
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 3, 2024
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 24, 2013
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
2532140-2008-00053
FDA Adverse Event
Injury
·Product code GDW·August 6, 2008
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·December 19, 2013
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·November 20, 2013
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
FDA Enforcement
Class II
·Terminated·Pega Medical Inc.·July 8, 2015
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.
FDA Enforcement
Class II
·Terminated·Pega Medical Inc.·December 2, 2015
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·October 31, 2013