15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)
FDA 510(k)
FDA Class 1
·Hematology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189398·AK3 Femoral Distal Locating Device, 2° Bushing
LEONE SPA
FDA UDI
LEONE SPA·08033707065654·INTRAORAL ELASTICS 2,5 oz 1/4" red
MSI
FDA UDI
Modern Surgical Instruments LLC·00810130203680·Round handle micro cervical curette 10", bwd an...
MSI
FDA UDI
Modern Surgical Instruments LLC·B419MSI9903020·
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit
FDA 510(k)
FDA Class 2
·Microbiology
PRESSURE MONITOR, MODEL 212
FDA 510(k)
FDA Class 1
·Orthopedic
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEO·June 19, 2006
COULTER® ACT DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC·Product code GKZ·December 7, 2010
HILL-ROM 100 LOW BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 7, 2013
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 15, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 7, 2014