10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
FDA 510(k)
FDA Unclassified
·Unknown
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
FDA 510(k)
FDA Class 2
·Microbiology
SUREONE INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
CUSTOM CLAVE 4 GANG 1O2 MANIFOLD ADMIN SET
FDA Adverse Event
Malfunction
·ICU MEDICAL INC.·Product code FMG·December 22, 2011
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·April 22, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·May 10, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 25, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018