9 results
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48ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Caption AI (Caption Guidance + Caption Interpretation)
FDA UDI
CAPTION HEALTH, INC.·00860003586341·
Caption AI (Caption Guidance + Caption Interpretation)
FDA UDI
CAPTION HEALTH, INC.·00860003586310·Caption AI (Caption Guidance + Caption Interpre...
Caption Guidance
FDA UDI
CAPTION HEALTH, INC.·00860003586334·The Caption Guidance software is intended to as...
Caption AI (Caption Guidance + Caption Interpretation)
FDA UDI
CAPTION HEALTH, INC.·00860003586303·The Caption Guidance software is indicated for ...
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
FDA Recall
Terminated
·Caption Health·Product code QIH·May 19, 2021
TECNIS IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code MJP·July 26, 2024
Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-4050. *** Size: Adult ... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free*** Distributed by: Cardinal Health McGaw Park, IL***.'
FDA Recall
Terminated
·Sandhill Scientific, Inc·Product code FAP·December 13, 2005
Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-5050. *** Size: Pediatric... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Labeling for the device reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free *** Distributed by: Cardinal Health McGaw Park, IL ***'.
FDA Recall
Terminated
·Sandhill Scientific, Inc·Product code FAP·December 13, 2005
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.
FDA Recall
Terminated
·Parks Medical Electronics, Inc·Product code DPW·August 8, 2012