11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BeautiLink SA
FDA 510(k)
FDA Class 2
·Dental
Advantage ALIF Trial Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068004·
Brisbane ALIF Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215018467·
Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VISU-LOCK 5MM CLIP APPLIER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 6, 2014
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·July 22, 2011
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·July 18, 2013
OT VITA ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·September 14, 2012
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