8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dental CBCT X-ray System
FDA 510(k)
FDA Class 2
·Radiology
FR.O.H. CALCANEUS REPAIR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BD VACUTAINER® ACD SOLUTION A BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·April 16, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2014
OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code LQC·August 30, 2011
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MRU·July 29, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024