12 results · 27ms · Sources: EU EUDAMED, US FDA

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COAXIAL ACUTE CATHETER

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

AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

BD VACUTAINER® CTAD BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 4, 2018

BD VACUTAINER® CTAD BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 31, 2018

BD VACUTAINER® CTAD BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 3, 2018

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Injury ·ANIMAS CORPORATION·Product code LZG·January 28, 2013

UNK STRYKER PAINPUMP PRODUCT

FDA Adverse Event
Injury ·STRYKER INSTRUMENTS KALAMAZOO·Product code MEB·December 8, 2010

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 14, 2014

ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024