13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STARBAND
FDA 510(k)
FDA Class 2
·Neurology
Simcoe Cortex Extractor, 23ga
FDA UDI
KATALYST SURGICAL LLC·00840096205718·Simcoe Cortex Extractor, 23ga
TruFit™
FDA UDI
Ortho Organizers, Inc.·00190707191818·TruFit 2.0 022 ROTH LL6/7 NC SBT -25T 5DOff DB ...
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376694856·PROXIMITY VA SELF-DRILL SCREW, 4.0 x 23mm
Insignia
FDA UDI
ALPHATEC SPINE, INC.·00190376329987·4.0mm Variable Angle, Self-Drilling Screw, Sing...
Segmental Plating System
FDA UDI
ALPHATEC SPINE, INC.·00190376545745·SPS VA Self-Drill Screw, 4.0 x 23mm
ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER
FDA 510(k)
FDA Class 2
·Anesthesiology
ZELTIQ COOLSCULPTING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AMISTEM H COLLARED FEMORAL STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code KWY·October 24, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 17, 2013
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 14, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 20, 2008
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·April 8, 2015