22 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
KaiBiLi Extended ViralTrans PBS
FDA UDI
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.·16972698600408·Viral Transport, PBS 3 mL
NEXT Medium Kid's Variety Prophy Paste Box 200
FDA UDI
Preventech·D024221113·NEXT Medium Kid's Variety Prophy Paste Box of 2...
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205003997·Luna Opal MB Mini .022 LL3 (-6°T +3°A)
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690129998·Retaining Bolt, PS or PS-C Insert, Revision Tib...
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221113150·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221113000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221113070·
PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·December 21, 2022
BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAMMOPATH
FDA 510(k)
FDA Class 2
·Radiology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523134090·Tesera ST, 22mm X 11mm X 13mm, Convex, T3
TALOS®-T
FDA UDI
SpineArt SA·07640332475836·TALOS-T (HA) LORDOTIC HA PEEK IBFD 6° L28 W10...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523149261·Straight Implant Trial 22mm x 11mm x 13mm
GALILEO NEO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·June 28, 2018
AEYE-DS RETINA SCREENING
FDA Adverse Event
Injury
·AEYE HEALTH INC.·Product code PIB·January 22, 2025
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·November 3, 2014
URETEX SUP URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·May 7, 2013
ADULT DUAL-HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·August 23, 2011
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020