13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LITTLE GRAFTER SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 5, 2016
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 19, 2025
PARIETEX UGYTEX PP ANTERIOR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·March 18, 2013
REACH ACCESS DAILY FLOSSER
FDA Adverse Event
Injury
·JOHNSON & JOHNSON HEALTHCARE PRODUCTS·Product code JES·May 8, 2008
SOFTCLIX ® PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·April 5, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 13, 2015
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; 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 IP1.P 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 IP2.P 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
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012