11 results
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19ms
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Sources: EU EUDAMED, US FDA
CARDON PHYSICAL THERAPY TABLE MODEL R27112
FDA 510(k)
FDA Class 1
·Physical Medicine
Synergy ODM
FDA 510(k)
FDA Class 2
·Radiology
EUGENONE
FDA 510(k)
FDA Class 2
·Dental
SPRINT QUATTRO SECURE MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 9, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 7, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
KENSTONE METAL·Product code ITJ·July 23, 2014
UNKNOWN RIGIDFIX CROSS PIN
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·July 1, 2019
UNKNOWN BIO-INTRAFIX
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code HWC·July 1, 2019
PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
FDA Enforcement
Class II
·Terminated·Ra Medical Systems Inc·August 6, 2014
Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·April 9, 2014
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