26 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEWPORT C250 AIR COMPRESSOR MODEL C250
FDA 510(k)
FDA Class 2
·Anesthesiology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125563·PowerChem Neoprene Exam Gloves, Extra Extra Large
LEONE SPA
FDA UDI
LEONE SPA·08033707065760·INTRAORAL ELASTICS 6,5 oz 3/8" orange
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981176990·Steep DTS Guide, 6mm
HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SPINAL MESH SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PYRAMESH C TITANIUM MESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code EZX·August 12, 2011
PYRAMESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·September 29, 2015
ASTERX EXPANDABLE CORPECTOMY SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MQP·March 4, 2019
ASTERX EXPANDABLE CORPECTOMY SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MQP·March 4, 2019
PYRAMESH C TITANIUM MESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·October 26, 2019
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 8, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2011
VITALITY DR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
PYRAMESH C TITANIUM MESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·June 27, 2020
PYRAMESH C TITANIUM MESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·April 22, 2019
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018
PYRAMESH® C TITANIUM MESH
FDA Adverse Event
Malfunction
·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code EZX·May 26, 2025
LEGION PS OXIN FEM SZ5 LT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018
6) Signa Excite (K041476 Signa Excite 1.5T and 3.0T) Signa Excite, 12x (K041476 Signa Excite 1.5T and 3.0T) 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