15 results
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29ms
·
Sources: EU EUDAMED, US FDA
PORTABLE OXYGEN UNIT SCA900
FDA 510(k)
FDA Class 1
·Anesthesiology
Regent
FDA UDI
SPINAL ELEMENTS·00840916114879·Regent ACP 2-Level, 43mm
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014605319·MAQUET 1130 SPLIT LEG 5" SOFTCARE
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221024794·Unitek(TM) Lingual Sheaths Slotted Tube UR/LL H...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450053164·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450180488·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450180242·
TRI-FIT FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
LASERPRO 16
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code OTN·April 26, 2013
PUMP IN STYLE ADVANCED
FDA Adverse Event
Malfunction
·MEDELA, INC·Product code HGX·April 7, 2011
POWERFLEX P3 PTA DILATATION CATHETER
FDA Adverse Event
Malfunction
·CORDIS EUROPA, N.V.·Product code LIT·July 21, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014