12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zenius Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL™ Sensi-Disc™ Ceftazidime/Avibactam 30/20 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902322184·BD BBL™ Sensi-Disc™ Ceftazidime/Avibactam 30/20 µg
PERFIX ILIAC SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ADEPT 1064/532/755 LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GLIDEWELL HT IMPLANT Ø4.3 X 8 MM
FDA Adverse Event
Malfunction
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·December 4, 2025
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 14, 2008
ENDOPATH** XCEL* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 2, 2011
PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·July 8, 2013
GLIDEWELL HT IMPLANT Ø4.3 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 1, 2025
QUICK CHECK ONE
FDA Adverse Event
Other
·DIAGNOSTIC SOLUTIONS, INC.·Product code CFR·March 5, 1997
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025