68 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QCT Pro Asynchronous Calibration Module, CliniQCT
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925017863·GRATE MALLEUS-TO-STAPES STRUT 1.78 MM DIAMETER ...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319741085·Baby Babcock Forceps 5-1/2" (13.8cm), delicate ...
SENORX BIOPSY DEVICE II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM
FDA 510(k)
FDA Class 2
·Cardiovascular
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 3, 2014
BASIC CONFIGURATION MODEL 6500
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 31, 2011
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 9, 2015
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD10C; Model Number: 722001; 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 FD10 OR Table; Model Numbers: 722033; 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 FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025