15 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Galapogos
FDA 510(k)
FDA Class 2
·Anesthesiology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694007122·1.6mm Pilot Drill, Mandible, Osteopower
ELMED
FDA UDI
ELMED INCORPORATED·00842180102880·DIATHERMY CABLE W/ TRIAX METAL CONNECTOR AND 2-...
ACUMED
FDA UDI
Acumed LLC·10806378014642·2.7mm x 30.0mm Locking Cortical Screw
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319706060·Takahashi Ethmoid Forceps 4-1/2" (11.4cm) shaft...
ACUMED
FDA UDI
Acumed LLC·10806378014659·2.7mm x 30.0mm Locking Cortical Screw
EAV COMBI-2
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO NC-STAT
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 24, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 1, 2013
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·April 25, 2013
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
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014