18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Altus Spine Monaco Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
inomed Medizintechnik GmbH·EINO2307669·MicroMacroElectrode 0.6 mm with depth stop., 5 ...
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295507215·DELTA XTEND Lateralized Glenosphere +6mm Trial ...
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295507284·DELTA XTEND Lateralized Glenosphere +6mm Trial ...
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295507161·DELTA XTEND Lateralized Glenosphere +6mm Trial ...
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295507338·DELTA XTEND Lateralized Glenosphere +6mm Trial ...
OXINIUM FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN DEPUY SZ 5 MBT TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code JWH·September 1, 2011
CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 17, 2008
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 26, 2024
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 6, 2022
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 15, 2020
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·February 9, 2023
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·December 6, 2024
CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
FDA Enforcement
Class II
·Terminated·Alcon Research Laboratories Ltd.·March 6, 2019