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

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Nitrile Powder Free Patient Examination Gloves, Blue Color

FDA 510(k)
FDA Class 1 ·General Hospital

Sklar

FDA UDI
SKLAR CORPORATION·30649111360774·DRESS. JAR 3 QT W/COVER PK 12

DIGITAL ELECTROCARDIOGRAPH

FDA 510(k)
FDA Class 2 ·Cardiovascular

MED GRAVITY SET, IMED PUMP SET

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FOGARTY

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES PR·Product code MJN·March 24, 2025

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MPRI·Product code DTB·June 7, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022