16 results · 23ms · Sources: EU EUDAMED, US FDA

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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