12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GRAB 'N GO PLUS, GRAB 'N GO DIGITAL
FDA 510(k)
FDA Class 1
·Anesthesiology
PEDICLE SCREW MONOAXIAL SCREW 5X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 10, 2019
CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
FDA 510(k)
FDA Class 2
·Hematology
LARGE VOLUME FLUID RESERVOIR
FDA 510(k)
FDA Class 2
·General Hospital
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 29, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·June 17, 2011
JAGWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code EZB·August 22, 2008
MYSPINE STANDARD DRILL GUIDE T07
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MNI·May 10, 2019
MUST PEDICLE SCREW 8X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 22, 2017
FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT
FDA Adverse Event
Malfunction
·MAQUET CV·Product code DSY·February 8, 2017
PEDICLE SCREW PEDICLE SCREW 7X45 (2 PCS)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWP·July 4, 2018
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·February 26, 2014