16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pantheon Spinal Pontus Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515235038·Malis-Style BP Fcps, str, .25mm tip, 8 3/4"
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
FDA 510(k)
FDA Class 2
·Radiology
ANTERIOR BUTTRESS PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
CARTIVA IMPLANT
FDA Adverse Event
Injury
·CARTIVA, INC·Product code PNW·November 13, 2020
CARTIVA IMPLANT
FDA Adverse Event
Injury
·CARTIVA, INC·Product code PNW·November 9, 2020
0.8% SELECTOGEN FOR GEL
FDA Adverse Event
Malfunction
·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·October 17, 2014
LIGACLIP** CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·June 21, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 7, 2011
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 4, 2016
SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS
FDA Adverse Event
Injury
·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 4, 2016
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 4, 2016
TFNA FEM NAIL Ø11 R 130° L360 TIMO15
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·February 23, 2023
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 5, 2018
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024