31 results
·
31ms
·
Sources: EU EUDAMED, US FDA
VISION -FORMERLY PDA- ALKALINE PHOSPHATASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994617767·LID 1850110 MAS 7.5 SCREW MODULE LID
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00148501100·
Hana/ProFx Femoral Hook Support
FDA UDI
MIZUHO ORTHOPEDIC SYSTEMS, INC.·00842430106804·
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690111580·Modular Stem 11mm x 100mm
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)
FDA 510(k)
FDA Class 1
·General Hospital
SYNTHES (USA) LCP MODULAR FOOT PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
ABDRDQ SSP UNITRAY KIT WITH TAQ POLYMERASE
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES CORPORATION·Product code MZI·December 26, 2013
ABDRDQ SSP UNITRAY KIT WITH TAQ POLYMERASE
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES CORPORATION·Product code MZI·December 26, 2013
AB/DR/DQ SSP UNITRAY W/TAQ 10T
FDA Adverse Event
LIFE TECHNOLOGIES CORP·Product code MZI·December 12, 2013
AB/DR/DQ SSP UNITRAY W/TAQ 10T
FDA Adverse Event
LIFE TECHNOLOGIES CORP·Product code MZI·December 12, 2013
AB/DR/DQ SSP UNITRAY W/TAQ 10T
FDA Adverse Event
LIFE TECHNOLOGIES CORPORATION·Product code MZI·December 12, 2013
AB/DR/DQ 2T SSP UNITRAY W/TAQ 20T
FDA Adverse Event
LIFE TECHNOLOGIES CORP·Product code MZI·December 12, 2013
AB/DR/DQ SSP UNITRAY W/TAQ 10T
FDA Adverse Event
LIFE TECHNOLOGIES CORP·Product code MZI·December 12, 2013
AB/DR/DQ 2T SSP UNITRAY W/TAQ 10T
FDA Adverse Event
LIFE TECHNOLOGIES CORP·Product code MZI·December 12, 2013
AB/DR/DQ SSP UNITRAY W/TAQ 10T
FDA Adverse Event
LIFE TECHNOLOGIES CORP·Product code MZI·December 12, 2013
AB/DR/DQ SSP UNITRAY W/TAQ 10T
FDA Adverse Event
LIFE TECHNOLOGIES CORP·Product code MZI·December 12, 2013
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Enforcement
Class II
·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 4, 2014
QUATTRODE
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 27, 2012