15 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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EASYDRILL AUTOSTOP CRANIAL PERFORATOR
FDA 510(k)
FDA Class 2
·Neurology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741414550·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674141455060·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1414550·14mm H x 14mm W x 55mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X14145580·14mm H x 14mm W x 55mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X141455120·14mm H x 14mm W x 55mm L x 12 degrees XLIF
K2M General Instruments
FDA UDI
VB Spine LLC·10888857581500·Split Tube Retractor Ø26x70 mm
SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 4, 2014
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 1, 2011
COBAS AMPLIPREP / COBAS TAQMAN 48 ANALYZER
FDA Adverse Event
Malfunction
·ROCHE DIAGNSOTICS, LTD.·Product code JJF·October 4, 2010
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 1, 2016
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017