21 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Saige-Q
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114193·OLIVE POLISHER 23G ANG 10MM
Zavation
FDA UDI
Zavation LLC·00197157000684·VARISYNC® ALIF, PEEK CAGE - 35X17MMX20°
Zavation NanoPrime ALIF Cage
FDA UDI
Zavation LLC·00197157026288·NANOPrime ALIF Cage 35 X 17MM X 20°
OTRES TOOTHBRUSH SANITIZER MODEL TB100W
FDA 510(k)
FDA Class 1
·Dental
DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
ZAVATION VARYISYNC ALIF RASPING TRIAL
FDA UDI
Zavation LLC·00197157067892·VARYISYNC ALIF RASPING TRIAL ...
Zavation
FDA UDI
Zavation LLC·00197157024284·VARISYNC® ALIF, WHITNEY CAGE - 35X17MMX20°
Zavation
FDA UDI
Zavation LLC·00197157025144·VARISYNC® ALIF, LABYRINTH® CAGE - 35X17MMX20°
Zavation
FDA UDI
Zavation LLC·00197157017842·VARISYNC® ALIF, F3D-Z CAGE- 35X17MMX20°
Zavation
FDA UDI
Zavation LLC·00197157009007·ALIF Sizer, 35 x 17mm
ZAVATION VARISYNC ALIF SIZER
FDA UDI
Zavation LLC·00197157072582·VARISYNC ALIF SIZER
ZAVATION ALIF SIZER
FDA UDI
Zavation LLC·00197157071080·ALIF SIZER
Zavation
FDA UDI
Zavation LLC·00197157008147·ALIF Sizer, 35 x 17mm
ZAVATION ALIF SIZER
FDA UDI
Zavation LLC·00197157070229·ALIF SIZER
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 17, 2008
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 3, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·February 17, 2021