12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Surgical Face Mask (M663BE, M663BT)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Walgreens
FDA UDI
WALGREEN CO.·00311917151472·Antibacterial Non-Stick Pads, Polyhexamethylene...
ELMED
FDA UDI
ELMED INCORPORATED·00842180137134·5 MM DIA., 32 CM CLASSIC BIPOLAR LAPAROSCOPIC F...
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996134514·LATERAL,CURETTE,PUSH CUP ASSY
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·March 16, 2021
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
FDA 510(k)
FDA Class 2
·Cardiovascular
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
FDA 510(k)
FDA Class 2
·Cardiovascular
TDXFLX SYSTEM
FDA Adverse Event
Injury
·ABBOTT MANUFACTURING, INC.·Product code JJQ·November 6, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 18, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·May 8, 2018
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