10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIMOVE
FDA 510(k)
FDA Class 2
·Physical Medicine
Sasmar Vanilla
FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008266·PERSONAL LUBRICANT
CLEARJET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLUID FILLED TEETHERS
FDA 510(k)
FDA Class 2
·Dental
OT VERIO SYNC METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 1, 2014
ALLEGRETTO WAVE
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·May 23, 2013
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011
TRANSMITTER MMT-7841ZW GST5G OUS
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PQF·February 19, 2026
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·October 17, 2018