14 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·December 31, 2014
CRYOPETTE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RUSCH BRONCHUS BLOCKER KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM R E-CROSS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 23, 2023
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 16, 2014
ADVIA CENTAUR CP TROPONIN ULTRA ASSAY
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·June 1, 2011
Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·August 30, 2017
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
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