21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Amia Automated PD System with Sharesource
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·December 15, 2020
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 12, 2023
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·February 15, 2024
XENMATRIX
FDA UDI
Davol Inc.·00801741074257·XenMatrix AB Surgical Graft, 15 cm x 25 cm
BONE SCREW, CORTICAL
FDA UDI
Biomet Orthopedics, LLC·00887868004674·
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837088552·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311515250·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321515250·
Canaveral®
FDA UDI
FLOSPINE LLC·B183115150250·Reduction Monoaxial Screw, 10.5mm x 25mm
ARX SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PIONEER SPINOUS PROCESS FUSION PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
REVO MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWP·June 7, 2013
ENDOTAK DSP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
TR BAND
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023
TR BAND
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023
TI QUARTER-TUBULAR PLATE WITH COLLAR 7 HOLES/55MM
FDA Adverse Event
Injury
·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HRS·January 2, 2018
iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016