10 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BAND-AID BRAND FLEXIBLE FABRIC BANDAGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58208018240·CURETTE
ACUMED
FDA UDI
Acumed LLC·10806378051852·7.3mm/6.5mm Cann. Screw Tray, Base
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209135554·
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 8, 2014
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD .·Product code MCM·October 23, 2012
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 16, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021