16 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MODIFIED ELISA FOR CHLAMYDIA
FDA 510(k)
FDA Class 1
·Microbiology
LEONE SPA
FDA UDI
LEONE SPA·08033707036128·WEB I MOL BANDS G8421-16+G2820-00 LR 32
Excel Tower Unit
FDA UDI
KOROS U.S.A., INC.·10840199538666·Excel Valve Tower Unit with 8800-503 Swiwel Arm
Sentinelle
FDA UDI
Philips Ds North America LLC·00884838115514·DS Sentinelle Breast coil, Biopsy Kit 3.0T Cons...
Invivo
FDA UDI
Philips Ds North America LLC·00884838115279·Kit, Enhanced Access, Bilateral Upgrade consist...
Invivo
FDA UDI
Philips Ds North America LLC·00884838115309·dS Breast 16 Biopsy Pack, 1.5T contains - 4 Lat...
Sentinelle
FDA UDI
Philips Ds North America LLC·00884838115507·DS Sentinelle Breast 16CH Coil Kit, 1.5T Consis...
Dunlee Sentinelle
FDA UDI
Philips Medical Systems Nederland B.V.·00884838120037·VS BREAST 1.5T 8CH TT FULL SET w PACKAGNG consi...
IMX TOXO IGM ANTIBODY ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
FDA Enforcement
Class III
·Terminated·Invivo Corporation·October 28, 2020
Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Invivo Corporation·March 11, 2020
OSCILLATING SAW ATTACH
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A.·Product code GFA·May 15, 2014
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010
UNKNOWN ENDO GIA SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·December 27, 2012
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
FDA Enforcement
Class II
·Terminated·Invivo Corporation·September 7, 2016