13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tri-Ad 2.0 Adams Tricuspid Band
FDA 510(k)
FDA Class 2
·Cardiovascular
MOBIS XL 0°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844001790·The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ impl...
SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK)
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø60
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 15, 2019
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·November 16, 2018
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·June 21, 2013
SUPER TURBOVAC 90 WITH INTEGRATED CABLE
FDA Adverse Event
Injury
·ARTHROCARE CORPORATION·Product code GEI·July 22, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·September 30, 2008
BD PLASTIPAK¿ CENTRIC LUER-LOCK HYPODERMIC THREE-PIECE SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 13, 2022
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018