11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Perfit FS Dental Zirconia Fully Sintered Block
FDA 510(k)
FDA Class 2
·Dental
LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 25, 2011
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 31, 2014
MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·July 12, 2013
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2020
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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