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