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

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NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System

FDA 510(k)
FDA Class 2 ·Orthopedic

6PW - CPRotector® ONE Deluxe - Poly White

FDA UDI
Certified Safety Manufacturing, Inc.·00766588030012·6PW - CPRotector® ONE Deluxe - Poly White

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113776·AIR INJECT CANNULA 27GA

24M - Salt River Project-21 - Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588022017·24M - Salt River Project-21 - Metal

Secure Wear USA Surgical Face Mask

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

STEALTHSTATION TREATMENT GUIDANCE PLATFORM

FDA 510(k)
FDA Class 2 ·Neurology

OT VERIO FLEX METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 7, 2016

VOYAGER RX CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 10, 2008

CAPSURE SENSE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 2, 2013

PULSE GENERATOR, PERMANENT, IMPLANTABLE

FDA Adverse Event
Death ·MEDTRONIC, INC.·Product code NVZ·September 6, 2017

BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

FDA Enforcement
Class II ·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025

MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

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

Achieva 1.5T

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