21 results · 20ms · Sources: EU EUDAMED, 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