9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
PRECISION? MONTAGE? MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 5, 2025
STRYKER IVAS BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOSCOPE STERILIZATION TRAY
FDA 510(k)
FDA Class 2
·General Hospital
BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·April 26, 2018
FREESTYLE FREEDOM
FDA Adverse Event
Injury
·Product code NBW·July 24, 2011
SYNREAM REAMER HEAD Ø14
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·June 17, 2013
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·October 1, 2014
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