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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Cook Cystostomy Catheter Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780463214·Kraff-Utrata Capsulorhexis Forceps, 4", Blunt
CALGAESEAL MODEL: CAS
FDA 510(k)
FDA Unclassified
·Unknown
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 26, 2025
UNK GEL BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·October 31, 2018
INSERTER F/TEN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·June 20, 2013
NDEHP 3CLV YSTE MACR
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code FPA·July 7, 2011
RAPID EXCHANGE BILIARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FGE·September 29, 2008
CHROMID® CARBA SMART
FDA Adverse Event
Malfunction
·BIOMERIEUX S.A.·Product code JSO·August 23, 2018
SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021