13 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Endoform Reconstructive Template
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
FDA 510(k)
FDA Class 2
·Cardiovascular
DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 16, 2025
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 7, 2011
CAPSUREFIXNOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 8, 2013
LASSOSTARNAV,10P,15MM DIA LOOP
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code DRF·February 22, 2023
LASSOSTAR CATHETER
FDA Adverse Event
Death
·BIOSENSE WEBSTER INC.·Product code DRF·December 30, 2020
LASSOSTAR NAV CIRCULAR MAPPING CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DRF·November 23, 2022
11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024