22 results · 36ms · Sources: EU EUDAMED, 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