20 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Myray- HYPERION X5
FDA 510(k)
FDA Class 2
·Dental
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704283754·
Simpact Tri-Fin
FDA UDI
Life Spine, Inc.·00190837063016·Pin Holder
Trial Liners (Neutral and 10 degree hooded)
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215038489·
ENDURANCE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295057338·FEMORAL STEM 12/14 TAPER ENDURANCE HIP STEM SIZ...
PARCUS PEEK CF PUSH-IN SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·April 29, 2002
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
URETEX SUP URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·May 29, 2013
COLLEAGUE PRE 1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Injury
·ZOLL MANUFACTURING CORPORATION·Product code MVK·May 6, 2015
FOGARTY
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code MJN·March 24, 2025
ENDURANCE CALCAR SZ3 200MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 14, 2023
COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·August 29, 2017
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·July 10, 2017
Allura Xper FD20/20; Catalog numbers: 722038
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024