29 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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T.E.D. SEQUENTIAL COMPRESSION SLEEVES
FDA 510(k)
FDA Class 2
·Cardiovascular
Ingenia Elition S
FDA UDI
Philips Medical Systems Nederland B.V.·00884838088108·Enables trained physicians to obtain cross-sect...
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 4, 2026
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 13, 2025
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
FDA Recall
Open, Classified
·Philips North America·Product code LNH·June 30, 2025
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9)
FDA 510(k)
FDA Class 2
·Radiology
PATRIOT® Lumbar Spacers, SUSTAIN® Spacers
FDA 510(k)
FDA Class 2
·Orthopedic
ADVIA CENTAUR TSH3-ULTRA (TSH3-UL)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JLW·April 30, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·October 10, 2012
SWAN NECK COIL CATH CA2 LEFT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·July 29, 2010
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
FDA Recall
Terminated
·Tepha Incorporated·Product code OOD·November 21, 2016
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 14, 2022
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
FDA Enforcement
Class II
·Ongoing·Philips North America·August 16, 2023
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
FDA Enforcement
Class II
·Ongoing·Philips North America·August 16, 2023
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·November 22, 2022
Ingenia Elition S, Model Number 781357. Nuclear Magnetic Resonance Imaging System
FDA Recall
Terminated
·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·December 21, 2018