13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SmartUs EXT-1M/3M
FDA 510(k)
FDA Class 2
·Radiology
SMOOTH STEINMANN PINS, DOUBLE END BAYONET POINT
FDA UDI
Biomet Orthopedics, LLC·00887868016820·
ECO-S
FDA 510(k)
FDA Class 2
·Dental
PORTABLE X-RAY SYSTEM, MODEL PORT-X II
FDA 510(k)
FDA Class 2
·Dental
STARKEY
FDA UDI
Starkey Laboratories, Inc.·00842318177063·
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 21, 2020
UNKNOWN SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code OJX·July 2, 2011
UNKNOWN PRODUCT- 32MM V40 ALUMIN CERAMIC HEAD
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code LZO·September 16, 2008
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·December 4, 2017
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·August 8, 2017
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·May 8, 2013