17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFIED URINARY CATHETER INTRODUCER (UCI)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ReLine
FDA UDI
Nuvasive, Inc.·00195377035486·RELINE-C Bender Tip, Ø4.0 Str Sagittal
Medline-Microtek
FDA UDI
Microtek Medical LLC·00748426142774·Patient Drape, Eye Drape, 46 cm x 46 cm (18 in ...
MAXUM DENTURE RESIN
FDA 510(k)
FDA Class 2
·Dental
URINE NEGATIVE CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
UniTip Catheter
FDA UDI
Unisensor AG·07640172972113·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971659·
UniTip Catheter
FDA UDI
Unisensor AG·07640172972274·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971642·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971604·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971611·
UniTip Catheter
FDA UDI
Unisensor AG·07640172973585·
UniTip Catheter
FDA UDI
Unisensor AG·07640172972106·
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 5, 2015
FORTIFY VR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·December 29, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024