16 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ULTRA BEAUTY
FDA 510(k)
FDA Class 2
·Neurology
PINNACLE®
FDA UDI
B. BRAUN MEDICAL INC.·04046964200823·PINNACLE® Single Chamber Mixing Container, EVA ...
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902097850·TAP 9112351 TCD ADJ
Truline
FDA UDI
Arbill Industries, Inc.·00850052602284·Made in Malaysia. Blue disposable Nitrile. Size...
Truline
FDA UDI
Arbill Industries, Inc.·10850052602205·
ADVIA Centaur® Wash 1
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414187273·Wash 1 Reagent - CENTAUR - CAL - 2x1500mL
Pro Lift Instruments
FDA UDI
Life Spine, Inc.·00190837030988·
BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
GRANDIO SO
FDA 510(k)
FDA Class 2
·Dental
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·May 14, 2013
PRECISION SPECTRA®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 24, 2014
CONTOUR
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·May 27, 2011
Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
FDA Enforcement
Class II
·Terminated·Covidien LLC·March 15, 2017
Allura Xper FD20/15; Catalog numbers: 722058
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
FDA Enforcement
Class II
·Terminated·Medrad Inc·February 27, 2013
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025