16 results · 20ms · Sources: EU EUDAMED, 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