16 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KLS MARTIN RIGID FIXATION - STERILE
FDA 510(k)
FDA Class 2
·Dental
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology
DRX-Revolution Mobile X-ray System
FDA UDI
CARESTREAM HEALTH, INC.·60889971060174·DRX-REVOLUTION MOBILE X-RAY SYSTEM
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·October 27, 2006
RENEGADE HI-FLO MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·April 16, 2013
ECHELON LINEAR CUTTER RELOAD
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 4, 2014
M2A MODULAR HEAD COMPONENT 28MM HEAD DIAMETER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 15, 2011
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
FDA Enforcement
Class II
·Terminated·Carestream Health Inc·February 15, 2017
DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
FDA Enforcement
Class II
·Terminated·Carestream Health Inc·July 5, 2017
DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
FDA Recall
Terminated
·Carestream Health Inc·Product code IZL·May 25, 2017
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
FDA Recall
Terminated
·Carestream Health Inc·Product code IZL·January 12, 2017
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and software for acquiring medical diagnostic images outside of a standard x-ray room. The DRX-Revolution Mobile X-Ray System has a motor for driving the system so that the operator does not have to push the system, but can walk behind the system while it is moving from one location to another.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc·December 24, 2014
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and software for acquiring medical diagnostic images outside of a standard x-ray room. The DRX-Revolution Mobile X-Ray System has a motor for driving the system so that the operator does not have to push the system, but can walk behind the system while it is moving from one location to another.
FDA Recall
Terminated
·Carestream Health Inc·Product code IZL·November 25, 2014
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023