13 results · 20ms · Sources: EU EUDAMED, 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