11 results
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25ms
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Sources: EU EUDAMED, US FDA
DIAMOND BLADE MICROMETER KNIFE
FDA 510(k)
FDA Class 1
·Ophthalmic
PageWriter
FDA UDI
Philips Medical Systems Hsg·00884838028784·PageWriter TC20 Cardiograph
PAGEWRITER TC 20 CARDIOGRAPH
FDA Adverse Event
Malfunction
·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
FDA 510(k)
FDA Class 2
·Dental
Stryker SDC3 HD Information Management System with Wireless Device Control Capability
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENPULSE DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014
COROX OTW-S 85-BP
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG.·Product code NKE·November 5, 2012
HUDSON NEONATAL VENTILATOR CIRCUIT, HEATED-WIRE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·September 24, 2010
PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
FDA Recall
Open, Classified
·Philips North America, LLC·Product code DPS·January 9, 2019
PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
FDA Enforcement
Class II
·Ongoing·Philips North America, LLC·February 27, 2019
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012