10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SILBRONCHO (RIGHT LUNG)
FDA UDI
FUJI SYSTEMS CORPORATION·04544050083942·SILBRONCHO Tube is intended for use in airway m...
SILBRONCHO (RIGHT LUNG)
FDA UDI
FUJI SYSTEMS CORPORATION·04544050123990·SILBRONCHO Tube is intended for use in airway m...
ERKA. PERFECT-ANEROID
FDA 510(k)
FDA Class 2
·Cardiovascular
TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)
FDA 510(k)
FDA Class 2
·Cardiovascular
RX WALLSTENT BILIARY ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FGE·October 16, 2008
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·July 3, 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
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012