9 results
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17ms
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Sources: EU EUDAMED, US FDA
CLEAR EYE GARTER SHIELD
FDA 510(k)
FDA Class 1
·Ophthalmic
SPINE BOARD
FDA 510(k)
FDA Class 1
·Physical Medicine
TEVADAPTOR Closed Drug Reconstitution and Transfer System
FDA 510(k)
FDA Class 2
·General Hospital
SOMATOM DEFINITION FLASH
FDA Adverse Event
Malfunction
·SIEMENS AG MEDICAL SOLUTIONS·Product code JAK·May 7, 2014
PUMP IN STYLE ADVANCED SHOULDER BAG
FDA Adverse Event
Other
·MEDELA, INC·Product code HGX·October 13, 2010
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·December 19, 2012
5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·October 28, 2015
5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Rod 390mm 5.0mm Unit Rod 410mm 5.0mm Unit Rod 430mm 5.0mm Unit Rod 450mm pedicle screw spinal system; Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·August 21, 2013
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025