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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NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
Modulus
FDA UDI
Nuvasive, Inc.·00195377049414·Modulus ALIF Trial, 10x34x28mm 20°SmDeep
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091982131·posteriors; shade BL1; size L; lower jaw
Trinias
FDA UDI
SHIMADZU CORPORATION·04540217058143·
PULSETAKER
FDA 510(k)
FDA Class 2
·Cardiovascular
NOSE BRACE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 5, 2023
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 8, 2013
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·January 14, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 5, 2014
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 26, 2023
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021