15 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EVOLUTION SPINE Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
GRYPHON PERMACORD
FDA UDI
Medos International Sàrl·10886705024629·GRYPHON P BR ANCHOR w/ PERMACORD TCP/PLGA Absor...
SEE H10
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·January 21, 2021
Akesis Galaxy RTi
FDA 510(k)
FDA Class 2
·Radiology
Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYRINGE 10ML SALINE XS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMF·September 20, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·August 16, 2011
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 2013
BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMF·October 1, 2020
GRYPHON P BR W PERMACORD
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·December 7, 2018
GRYPHON P BR W PERMACORD
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·December 7, 2018
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
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