31 results · 23ms · Sources: EU EUDAMED, US FDA

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EZ CONNECT

FDA 510(k)
FDA Class 2 ·Dental

CUSTOM PROCEDURE KIT

FDA UDI
MEDIVATORS INC.·40677964003361·CUSTOM PROCEDURE KIT

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014602905·Transfer Board with Safety Notches

CURE™ ACP

FDA UDI
MEDITECH SPINE, LLC·B167700003460·

CURE™ ACP

FDA UDI
MEDITECH SPINE, LLC·B167S1700003460·

KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)

FDA 510(k)
FDA Class 2 ·Orthopedic

RADIOCAMERAS EXTRACRANIAL SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

OXYGENATOR

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·August 12, 2025

V 2.0 FIRM EXT PEBAX

FDA Adverse Event
Injury ·CONCENTRIC MEDICAL·Product code NRY·March 12, 2013

RESTORE PRIME ADVANCED

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·February 18, 2011

PHILLIPS

FDA Adverse Event
Malfunction ·PHILLIPS·Product code DXN·February 15, 2008

SMR GLENOID BASEPLATE SMALL-R

FDA Adverse Event
Injury ·LIMACORPORATE SPA·Product code KWS·July 2, 2021

BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017

Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 5, 2014

BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

BrightView XCT

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017

BrightView XCT , Model Number 882482

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019

BrightView XCT, Gamma Camera, Product Code 882482

FDA Enforcement
Class II ·Ongoing·Philips North America·January 17, 2024

BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·September 14, 2016

BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016