10 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Single-use Flexible Rhinolaryngoscope; Digital Video Monitor
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ELMED
FDA UDI
ELMED INCORPORATED·00842180166141·RONGEUR, PITUITARY, 4MM, STRAIGHT, Medtronic St...
EXPORT ADVANCE ASPIRATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LAC-MAC LIMITED INNERBLOC O.R. GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 1, 2011
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 16, 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
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025