15 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cerebra Sleep System
FDA 510(k)
FDA Class 2
·Neurology
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193100807·EVOS Straight HA PEEK, 7mm x 8mm x 26mm, Flat 5...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130070·Rocker, One Piece
Link OptiStem
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575284122·Modular stem, cemented, CoCrMo, oval
BELLEGLASS HP ENAMEL 2
FDA 510(k)
FDA Class 2
·Dental
BIONIME DIABETES MANAGEMENT SYSTEM VI.0
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 17, 2014
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
2520274-2014-01038
FDA Adverse Event
Injury
·SYNTHES, USA·Product code HWC·October 30, 2014
SETROX S 45
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·August 9, 2011
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 9, 2013
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·March 16, 2022
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021