15 results · 29ms · Sources: EU EUDAMED, 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