24 results · 20ms · Sources: EU EUDAMED, US FDA

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ODISSEY TISSUE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Biomet® Knee System

FDA UDI
Biomet Orthopedics, LLC·00887868247972·

Biomet® Knee System

FDA UDI
Biomet Orthopedics, LLC·00887868558689·

BIOMET KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304008328·

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587T1412340·14mm TLIF Implant 12mm Wide 34mm Length

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587T14123470·14mm TLIF Implant 12mm Wide 34mm Length 7 Degrees

VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY

FDA 510(k)
FDA Class 1 ·Microbiology

HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

AP409 -PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FPA·December 18, 2025

AP205 - INFUSION SET WITH NON-VENTED SPIKE, 1.2UM FILTER AND NEEDLE Y-SITE

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 5, 2024

AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 6, 2024

AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 17, 2024

NEEDLE SFTYGLD 25X1 RB MCK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·June 7, 2021

INCORPORATE

FDA UDI
SPINAL ELEMENTS·00840606151542·14 X 12 CERVICAL TRIALS 34MM 0° LORDOSIS

INCORPORATE

FDA UDI
SPINAL ELEMENTS·00840606151733·14 X 12 CERVICAL TRIALS 34MM 10° LORDOSIS

AP403 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FPA·March 31, 2026

AP407 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDLELESS Y-SITE

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FPA·March 4, 2026

KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB

FDA Adverse Event
Malfunction ·KIMBERLY-CLARK CORPORATION CONWAY MILL·Product code HEB·June 21, 2018

ADAPTA DR

FDA Adverse Event
Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 3, 2013

THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·October 3, 2014