11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Z7 Zirconia Implant System
FDA 510(k)
FDA Class 2
·Dental
Tyber Medical
FDA UDI
Tyber Medical, LLC·M695302P221488S1·PLIF 22mm x 8mm x 14mm x 8 °, PEEK, Sterile
Tyber Medical
FDA UDI
Tyber Medical, LLC·M695502P221488S1·PLIF 22mm x 8mm x 14mm x 8 °, TyPEEK, Sterile
SURECAN SAFETY HUBER NEEDLE INFUSION SETS
FDA 510(k)
FDA Class 2
·General Hospital
JMS SAFE WING CATH (SWC)
FDA 510(k)
FDA Class 2
·General Hospital
MWA PERCUTANEOUS ANTENNA 17CM
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code NEY·August 17, 2011
ANALYTICAL E MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code DHA·November 5, 2008
JUVEDERM ULTRA XC/LIDO (VOLUME UNKNOWN)
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·July 9, 2013
1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 17, 2014
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020