33 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PowerPICC SOLO
FDA UDI
Bard Access Systems, Inc.·00801741122712·Catheter Placement Kit
LEGION
FDA UDI
Smith & Nephew, Inc.·00885556701430·LEGION PRESSFIT STEM 17MM X 160MM
LIFEPAK® 500 Automated External Defibrillator
FDA UDI
PHYSIO-CONTROL, INC.·00721902559914·LP500AACBAZZZZZLP500EECGIAAAAAAZZZZZ
Millennia Software
FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C4MA080·
Millennia Software
FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C4MA000·
Millennia Software
FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C4MA020·
EliA IgM Calibrator Strip
FDA UDI
Phadia AB·07333066012971·EliA IgM Calibrator Strip
AESCULAP BONE WAX
FDA 510(k)
FDA Unclassified
·Unknown
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB
FDA 510(k)
FDA Class 2
·Immunology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·December 19, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·December 19, 2024
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·May 27, 2026
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·January 25, 2026
BONE WAX 24X2.5G
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MTJ·October 30, 2019
ASR ACETABULAR IMPLANT 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 12, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·February 24, 2011
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code FGE·February 15, 2008
BONE WAX 24X2.5G
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MTJ·May 7, 2019
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015