17 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARCHITEX SPACE MAINTENANCE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Utrecht Interstitial Fletcher CT/MR Applicator
FDA UDI
Nucletron B.V.·08717213034778·Interstitial Ovoid (left) 20mm 25°, R10
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973271·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971178·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172972991·
MEDIFACE PACS
FDA 510(k)
FDA Class 2
·Radiology
V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 22, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 7, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·May 13, 2013
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 11, 2014
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 20, 2011
DONJOY FULLFORCE,ACL,STD,CALF,LT,M
FDA Adverse Event
Injury
·DJO, LLC·Product code ITQ·June 26, 2019
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024