12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HENKE JECT PRESSURE SYRINGE
FDA 510(k)
FDA Class 2
·Dental
LEONE SPA
FDA UDI
LEONE SPA·08033707029021·WEB 1ST MOLAR BANDS n.UL 24
BREATHID HP SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN
FDA 510(k)
FDA Class 2
·Cardiovascular
WALKMED® 150 ML RESERVOIR BAG
FDA Adverse Event
Malfunction
·WALKMED TECHNOLOGIES, LLC·Product code FRN·September 5, 2025
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 23, 2014
M2A-MAGNUM 42-50 TPR INSRT STD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 13, 2012
DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
PFNA BLADE PERF L95 SST
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·June 20, 2018
Pressure Monitoring Set, C-PMS, G02838
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 10, 2020
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
FDA Enforcement
Class II
·Completed·Cook Incorporated·July 20, 2022
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018