13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PM2 System and ECGuide Connector
FDA 510(k)
FDA Class 2
·General Hospital
ANATOMIC PEEK CERVICAL FUSION SYSTEM
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994360458·IMPLANT 4240486 ANATOMIC C 18X16X 14MM
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994305015·IMPLANT 6240486 ANATOMIC 18X16X14MM
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000856809·IMPLANT 6240486 ANATOMIC 18X16X14MM
Oticon
FDA UDI
Sbo Hearing A/S·05714464058228·OTICON ZIRCON 1 MINIRITE T C090 DEMO
Bentely the Bear Pediatric Nebulizer
FDA UDI
ARISE MEDICAL LLC·00372217005049·Bentely the Bear Pediatric Nebulizer
Kentrospine PSS Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDIPACS
FDA 510(k)
FDA Class 2
·Radiology
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·December 19, 2019
AFFINITY DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·September 9, 2011
8010042-2008-00127
FDA Adverse Event
Malfunction
·Product code CBK·August 26, 2008
IRRIG CLIP, MED, LONG/-S, TURQ-L
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POER TOOLS·Product code FRN·July 17, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025