12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
FDA 510(k)
FDA Class 2
·Anesthesiology
XLIF
FDA UDI
Nuvasive, Inc.·00887517191632·XLIF Blade, 130mm Lung Retractor Narrow
HEALIX ADVANCE PERMACORD
FDA UDI
Medos International Sàrl·10886705024810·HEALIX ADVANCE BR ANCHOR w/ PERMACORD TCP/PLGA ...
ANSWATCH WRIST MONITOR MODEL TS-0411
FDA 510(k)
FDA Class 2
·Cardiovascular
ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TVL LEAD, RIGHT VENTRICULAR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 17, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 2013
XP-XP Tibial Tray - Interlok 71 mm Item # 195755
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Philips Azurion system; Software Version Number: R3.1;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 28, 2026
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018