37 results · 19ms · Sources: EU EUDAMED, US FDA

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EZ CONNECT RESIN

FDA 510(k)
FDA Class 2 ·Dental

ASIA MED

FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282500283·asia-med Standard No. 2: uncoated acupuncture ...

ASIA MED

FDA UDI
asia-med GmbH·04251282507602·asia-med Standard No. 2: uncoated acupuncture ...

PowerPICC

FDA UDI
Bard Access Systems, Inc.·00801741087462·Catheter Placement Kit

Zavation

FDA UDI
Zavation LLC·00842166122086·3-Level, 57mm Cervical Plate

Electric Toothbrush

FDA UDI
Access Dental Lab, LLC·00850007728069·Power toothbrush-Blurple-ECOMM

CURE™ ACP

FDA UDI
MEDITECH SPINE, LLC·B167700003570·

ESU Shroud

FDA UDI
I.C. MEDICAL, INC.·00817688021193·

SERVO-AIR LITE

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code MNT·March 31, 2025

SPACELABS HEALTHCARE

FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522121920·EP JUNCTION LEADSET,PM-3,EU

CURE™ ACP

FDA UDI
MEDITECH SPINE, LLC·B167S1700003570·

IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RADIONICS LUMBOPERITONEAL SHUNT

FDA 510(k)
FDA Class 2 ·Neurology

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Death ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 12, 2013

INFINITI VISION SYSTEM OZIL

FDA Adverse Event
Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·February 18, 2011

FOAM COVERED BREAST IMPLANT

FDA Adverse Event
Injury ·Product code FTR·January 17, 2008

BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 3, 2014

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