10 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COUNT-A-DOSE
FDA 510(k)
FDA Class 2
·General Hospital
INPUT™ PS
FDA UDI
MEDTRONIC, INC.·00643169014138·INTRDCR 883311 8F 5PK 8F 11CM INPUT
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011883311220·dentaform® Band, tooth 26, size 11/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011883311180·dentaform® Band, tooth 26, size 11/Roth 18
AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Ivenix Infusion System (IIS)
FDA 510(k)
FDA Class 2
·General Hospital
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 20, 2014
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 20, 2010
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 21, 2012
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024