15 results
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22ms
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Sources: EU EUDAMED, US FDA
COMPUTER INTERFACE IL 814
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENDOSCOPIC CO2 REGULATION UNIT UCR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ELMED Laparoscopic Instruments and Accessories
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWY·April 30, 2014
UNKNOWN PINNACLE METAL HIP LINER
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 10, 2012
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·July 29, 2010
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024
Intera 1.5T Achieva Nova-Dual Product Number: 781173;
FDA Enforcement
Class II
·Ongoing·Philips North America·June 18, 2025
Intera 1.5T Achieva Nova-Dual Product Number: 781173;
FDA Recall
Open, Classified
·Philips North America·Product code LNH·May 29, 2025
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
FDA Recall
Open, Classified
·Philips North America·Product code LNI·January 3, 2024
Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System
FDA Recall
Terminated
·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·December 21, 2018
Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 24, 2024
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8) Achieva 1.5T Model 781382 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·April 25, 2018
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8) Achieva 1.5T Model 781382 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code LNH·March 16, 2018