285 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LANX ANTERIOR PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NITRILE POWDER-FREE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
FDA 510(k)
FDA Class 2
·Neurology
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·May 3, 2013
SPACEMAKER STRUCTURAL BALLOON TROCAR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY USSC·Product code GCJ·September 9, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 5, 2011
COCR BALL HEAD 12/14 22 SIZE S -2,5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·January 4, 2021
VERSAFITCUP ACETABULAR SHELL CC Ø 54
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·April 27, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 21, 2025
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 27, 2019
COCR BALL HEAD 12/14 Ø 28 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·May 24, 2018
COCR BALL HEAD 12/14 Ø 28 SIZE XL +7
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·May 17, 2018
BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·July 13, 2020
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 3, 2019
COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·February 17, 2017
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 18, 2019
COCR BALL HEAD 12/14 Ø 22 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·January 10, 2019
COCR BALL HEADS 12/14 28 SIZE L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code MBH·October 18, 2013
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·October 30, 2013
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·October 30, 2013