14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bio-Medicus Adult Cannulae and Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·May 27, 2024
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·May 21, 2025
DIMENSION(R) CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code LCP·October 6, 2014
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·June 3, 2013
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·June 21, 2011
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·December 21, 2016
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·November 26, 2025
SLIDING MECHANISM
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HTD·August 31, 2016
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code CBK·April 18, 2022
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Enforcement
Class I
·Ongoing·GE Healthcare, LLC·June 15, 2022
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·October 17, 2018