22 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MODEL 418 SERIES WALKERS
FDA 510(k)
FDA Class 1
·Physical Medicine
NAVIGATION MARKER, REFLECTIVE MARKER SPHERES
FDA 510(k)
FDA Class 2
·Neurology
M.U.S.T. PEDICLE SCREW 7X45
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MNI·January 20, 2017
PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020
PEDICLE SCREW 03.50.030 PEDICLE SCREW 7X40
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWP·February 3, 2020
N/A
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·June 8, 2013
FISH SP DEVICE
FDA Adverse Event
Malfunction
·MORRIS INNOVATIVE, INC.·Product code MGB·June 17, 2011
LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC·Product code MAF·September 5, 2008
MECTALIF POSTERIOR
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·October 8, 2025
PERF CON TIB BRG LRG 22X60
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020
NON-POROUS PERF TIB TRAY-LGE
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020
PERF ANAT TIBIAL STEM 120X14X5
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020
MECTALIF OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X7 L0°
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MAX·November 10, 2017
PREVENA PLUS INCISION MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC·Product code OMP·September 24, 2021
PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
MECTALIF (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X7 L5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·April 29, 2020
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·May 23, 2019
MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·May 25, 2023