9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583031927·ET40 B 105, 2.4G NFM DPB DG DEMO ENCHANT 40
DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN
FDA 510(k)
FDA Class 2
·General Hospital
BTI DENTAL IMPLANT 5.5-6.5
FDA 510(k)
FDA Class 2
·Dental
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 9, 2008
GYNNIE OB-GYN STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 28, 2011
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 26, 2013
PENUMA IMPLANT
FDA Adverse Event
Injury
·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018