13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CIMARA
FDA 510(k)
FDA Class 2
·Dental
Luxatemp® Fluorescence
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1105890·Temporary crown and bridge material automix sys...
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2022
MICROWAVAE DELIVERY SYSTEM #MW2000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
FDA 510(k)
FDA Class 2
·Microbiology
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·February 24, 2014
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 2, 2013
INTRAVIA CONTAINER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FPA·May 3, 2013
GORE® DRYSEAL SHEATH
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DYB·September 23, 2014
ENDOSCOPIC MULTIFEED STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·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
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024