9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
CAPTIA(R) SYPHILIS M, MODIFICATION
FDA 510(k)
FDA Class 2
·Microbiology
ReLine
FDA UDI
Nuvasive, Inc.·00195377069030·RELINE C Screw, 4.5x24mm MA
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837014742·
CHEMFIL II CAPS
FDA 510(k)
FDA Class 2
·Dental
MODEL F3 FLIP UP SUNGLASSES W/POLORIZED COMPUTER
FDA 510(k)
FDA Class 1
·Ophthalmic
PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code FDI·November 22, 2010
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·July 1, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 30, 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