10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROFEMUR TAPERED HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
Entuit Thrive
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00827002356153·Entuit Gastrostomy BR Balloon Retention Feeding...
3M QUIK TEMP TEMPORIZATION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
ETYMOTIC RESEARCH ER-10D OAE PROBE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 8, 2013
UNKNOWN TRILOGY ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·March 29, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 27, 2014
BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·May 27, 2020
TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 24, 2016
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Enforcement
Class II
·Ongoing·Genesee BioMedical, Inc.·June 6, 2018