20 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DeRoyal Angiography Kits
FDA 510(k)
FDA Class 2
·Cardiovascular
AGC KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304242982·
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575328420·Femoral Segment,in combination with Size 4
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575340798·Femoral Segment,in combination with Size 4
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575328079·Femoral Segment,Size 4
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575328413·Femoral Segment,in combination with Size 4
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575340781·Femoral Segment,in combination with Size 4
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575340859·Terminal,for Femoral Segment
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575328406·Femoral Segment,in combination with Size 4
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575328086·Femoral Segment,Size 4
GE 1.5T SIGNA HDE MR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SANICLAVE 102, MODEL RS-SC-102
FDA 510(k)
FDA Class 2
·General Hospital
ENDO-MODEL KNEE SYSTEM / LINK ENDO-MODEL EVO KNEE
FDA Adverse Event
Injury
·WALDEMAR LINK GMBH & CO. KG·Product code KRO·January 9, 2025
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·June 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 8, 2014
TW POWER SUPPLY, US
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code HQO·June 17, 2011
UNKNOWN RICKHAM RESEVOIR
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·November 28, 2023
LINK ENDO-MODEL ROTATIONAL KNEE SYSTEM MODULAR
FDA Adverse Event
Malfunction
·WALDEMAR LINK GMBH & CO. KG·Product code KRO·June 7, 2013
4) Signa HDe (K052978 GE 1.5T Signa HDe MR System) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, 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 HDe system 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 Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023