23 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
Bio2 Technologies
FDA UDI
BIO2 TECHNOLOGIES, INC.·B01010000621·VITRIUM C
MEDIUM, 7 x 23
QB1 NMES System
FDA UDI
Motive Health, Inc.·00854816006363·QB1 Post-Op Brace, NMES System; 2X-LARGE, REGUL...
Midmark IQecg® Digital ECG
FDA UDI
MIDMARK CORPORATION·00841709100321·The IQecg® from Midmark is an easy-to-use, digi...
PERSONA®
FDA UDI
Zimmer, Inc.·00889024228764·
PERSONA®
FDA UDI
Zimmer, Inc.·00889024228757·
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
FDA 510(k)
FDA Class 2
·Radiology
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
FDA 510(k)
FDA Class 2
·Clinical Toxicology
WALLACH ULTRA FREEZE
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GEH·August 9, 2023
EMAX 2 MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·March 8, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 24, 2011
N'VISION
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·February 15, 2008
CER BIOLOXD OPTION HD 40MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·October 21, 2021
STEM: AMISTEM P AMISTEM-P STD STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 17, 2021
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
Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·July 10, 2024
BrightView, Gamma Camera System, Product Code 882480.
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016
882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 22, 2017