12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
FDA 510(k)
FDA Class 2
·Cardiovascular
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MED GRAVITY SET, IMED PUMP SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HYDROGEN PEROXIDE CONTACT SOLUTION, 3%
FDA Adverse Event
Injury
·WALGREENS·Product code LPN·June 28, 2015
*
FDA Adverse Event
Malfunction
·ALLEN A HILL-ROM COMPANY·Product code FWZ·June 10, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 29, 2013
LAMITRODE TRIPOLE 16C
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 29, 2014
Non-sterile drape
FDA Enforcement
Class III
·Terminated·Novadaq Technologies, Inc.·December 3, 2014
LUNA Chest, Model No. LU4006
FDA Enforcement
Class III
·Terminated·Novadaq Technologies, Inc.·December 3, 2014
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025