73 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUADCUT
FDA 510(k)
FDA Class 2
·Neurology
13 CM TRICUT BLADE
FDA Adverse Event
Malfunction
·MEDTRONIC ENT (JACKSONVILLE)·Product code HAW·July 23, 2015
CURVED SINUS BURS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EQJ·June 2, 2014
ZAVATION F3D-Z CIF
FDA UDI
Zavation LLC·00197157020705·F3D-Z CIF 14mmx18mmx8mm - 6deg
ALEUTIAN Interbody Systems
FDA UDI
VB Spine LLC·10888857560772·Disc Spreader Size 12 mm
LINK Instruments - Impactors, extractors and insertion
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575229581·Orthopaedic prosthesis instrument, reusable - G...
REAMER SHAFT, MOD, TRINKLE 8.0X284 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HWE·February 13, 2012
OTI BONE CEMENT PLUG
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
FDA 510(k)
FDA Class 2
·Radiology
ORTHOBLAST-II PASTE
FDA Adverse Event
Injury
·ISOTIS ORTHOBIOLOGICS, INC·Product code MBP·June 2, 2015
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·May 24, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 30, 2014
MAXIMO VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·June 16, 2011
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·July 27, 2016
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