16 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Terason uSmart 3200T Plus Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116023493·THULIO LL-R TM 1000µM 3M PERF. FIBER 3ST 10X USE
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116023295·400 Micron SU Thulio Performance 3m Fiber
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383512671·"An absorbent paper points is an endodontic pap...
ECAT VISION PET SCANNER, MODELS 3000 & 5000
FDA 510(k)
FDA Class 2
·Radiology
LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 12, 2022
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·October 28, 2011
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·October 27, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
ACCU-CHEK ® PERFORMA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 14, 2016
CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 10, 2024
ENDURANT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·June 2, 2016
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021