8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CAT. NO. S-5300-E BIRTHING BED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Buttons
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746114588·LINGUAL BUTTON DEEP CURVED PAD
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE
FDA 510(k)
FDA Class 2
·General Hospital
Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4
FDA 510(k)
FDA Class 2
·Orthopedic
ACCOLADE TMZF HIP STEM #4
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·June 5, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 4, 2010
TRANSRADIAL ACCESS TRAY
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DYB·November 12, 2012
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025