10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGICARE STERILE SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·00840117408241·
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·10840117400242·
ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA
FDA 510(k)
FDA Class 1
·Microbiology
RADIATION PROTECTION GLOVES
FDA 510(k)
FDA Class 1
·Radiology
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 17, 2013
PUREPOINT
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQF·May 27, 2014
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·January 9, 2013
ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code NTE·November 22, 2010
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024