13 results · 23ms · Sources: EU EUDAMED, 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