20 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BONE SCREW, CORTICAL
FDA UDI
Biomet Orthopedics, LLC·00887868004711·
ProLift
FDA UDI
Life Spine, Inc.·00190837138035·
ProLift
FDA UDI
Life Spine, Inc.·00190837086275·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694046947·PrimaLIF LLIF PEEK Implant, 15mm X 18mm X 45mm,...
Canaveral®
FDA UDI
FLOSPINE LLC·B183115150450·Reduction Monoaxial Screw, 10.5mm x 45mm
GENESIS IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
L.E. DEMETRON II
FDA 510(k)
FDA Class 2
·Dental
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·December 15, 2020
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 12, 2023
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
REVEAL XT
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code DSI·June 7, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·June 28, 2011
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·February 15, 2024
Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014
GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 8, 2013
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and Ovation HD) GE 1.5T SIGNA HDe MR SYSTEM GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (4) WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (5) WITH EXCITE MR SYSTEM The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 21, 2013