15 results · 21ms · Sources: EU EUDAMED, US FDA

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GLIDE DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Ophthalmic Spatula

FDA UDI
KATENA PRODUCTS, INC.·00841668102275·DALK CORNEAL DISSECTOR

Freedom Pedicle Screw System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027292·

G7 DUAL MOBILITY LINER 46MM G

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·May 3, 2017

SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE

FDA 510(k)
FDA Class 1 ·General Hospital

SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·October 1, 2014

INTERLOCK?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KRD·May 29, 2013

ADAPTA DR

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·June 16, 2011

G7 ACETABULAR LINER

FDA Adverse Event
Malfunction ·BIOMET ORTHOPEDICS·Product code PBI·May 3, 2017

INTELLIVUE MX500 PATIENT MONITOR

FDA Adverse Event
Death ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·December 4, 2023

EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDS·July 22, 2022

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020