9 results
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26ms
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Sources: EU EUDAMED, US FDA
GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)
FDA 510(k)
FDA Class 1
·Microbiology
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809642650·OPAQUE MATERNITY 20-30 MM HG THIGH HIGH ZIG ZAG...
ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
FDA 510(k)
FDA Class 2
·Dental
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VIVA QUAD XT
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 8, 2012
ALIF SIZER HANDLE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code GDZ·June 23, 2015
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012