16 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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BriefCase-Triage
FDA 510(k)
FDA Class 2
·Radiology
TIGERSHARK
FDA UDI
Choice Spine, LP·00840996185776·TIGER SHARK THTL,TRIAL 25X14X6DEGREE
Puritan
FDA UDI
Puritan Medical Products·00609576390166·Sterile Foam Tipped Applicators
Cogent Lateral Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
OSTEOCURE RESORBABLE BEAD KIT
FDA 510(k)
FDA Class 2
·Orthopedic
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·January 28, 2025
Puritan
FDA UDI
Puritan Medical Products·00609576140020·Sterile Foam Tipped Applicators
Puritan
FDA UDI
Puritan Medical Products·00609576390180·Sterile Foam Tipped Applicators
CMD 25-1406 PROMADE ELBOW
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code JDC·March 12, 2026
Puritan
FDA UDI
Puritan Medical Products·00609576140037·Sterile Foam Tipped Applicators
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·September 13, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 14, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 29, 2013
Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.
FDA Recall
Terminated
·Puritan Medical Products Co., LLC·Product code KXG·December 22, 2014
Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.
FDA Enforcement
Class II
·Terminated·Puritan Medical Products Co., LLC·March 25, 2015
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026