17 results · 28ms · Sources: EU EUDAMED, 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