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

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Veuron-Brain-pAb2

FDA 510(k)
FDA Class 2 ·Radiology

RIGIDFIX

FDA UDI
DEPUY MITEK, LLC·10886705003143·RIGIDFIX TIBIAL ST GUIDE BLOCK

Ophthalmic Hooks

FDA UDI
KATENA PRODUCTS, INC.·00841668114308·SINSKEY IOL HOOK ANG (BX/3)

SCANLAN® V.I.P™ Instrument Sterilization Trays

FDA UDI
SCANLAN INTERNATIONAL INC·00846159018592·Metal Sterilization Tray silver-grey color

CADD

FDA UDI
ICU MEDICAL, INC.·10610586016998·

CADD

FDA UDI
ICU MEDICAL, INC.·00610586016977·

CADD

FDA UDI
ICU MEDICAL, INC.·10610586016981·

ADVIA Centaur® Cuvettes

FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414221588·Laboratory analyser cuvette, IVD

ULTRASAFE DENTAL INJECTION SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

VPAP ADAPT

FDA 510(k)
FDA Class 2 ·Anesthesiology

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 28, 2008

REMB MICRO DRILL

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·August 4, 2011

GYNECARE GYNEMESH* PS

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTO·July 9, 2013

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

Achieva 1.5T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·November 29, 2023

Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021