16 results
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18ms
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Sources: EU EUDAMED, US FDA
ASTRA-VAC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Ingenia
FDA UDI
Philips Medical Systems Nederland B.V.·00884838099043·Enables trained physicians to obtain cross-sect...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111310423·JACKSON TUBE IMP SHORT STL #5
Vinyl Patient Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT
FDA 510(k)
FDA Class 2
·Dental
DRILL STOP
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code FZX·April 30, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 11, 2012
HHARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·February 12, 2008
Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
FDA Recall
Open, Classified
·Philips North America·Product code LNH·June 30, 2025
Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 13, 2025
Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 2, 2024
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·September 3, 2024