29 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
JILCO TRACTION-FLEXION CHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
K-ASSAY AT-III
FDA 510(k)
FDA Class 2
·Hematology
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·December 13, 2021
ROI-A IMPLANT HOLDER
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code OVD·July 25, 2019
CONSULT HCG TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 13, 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code DXC·January 27, 2011
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·August 12, 2014
TEMPOROMANDIBULAR JOINT SMALL RIGHT FOSSA COMPONENT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·May 24, 2016
TEMPOROMANDIBULAR JOINT SMALL LEFT FOSSA COMPONENT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·May 24, 2016
CROSS-DRIVE EMERGENCY SCREW 3.2 X 10 MM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·May 24, 2016
2.7 X 10 MM HIGH TORQUE CROSS-DRIVE SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·May 24, 2016
2.0 X 11 MM FOSSA CROSS-DRIVE SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·May 24, 2016
OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018
OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018
OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018
CONSULT HCG URINE CASSETTE 5001 25T
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·September 9, 2019
ROI-A IMP HOLD THREADED ROD
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code OVD·July 18, 2019
CERTAIN® GOLD-TITE® HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·May 15, 2017