8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex Spine Endoscope
FDA 510(k)
FDA Class 2
·Orthopedic
InSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00810030810254·Femoral Head, 36mm, +4mm, Ceramic
QUADRANT RETRACTOR SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·November 11, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 24, 2011
MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 40 MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code MNH·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025