13 results
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18ms
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Sources: EU EUDAMED, US FDA
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VuePoint
FDA UDI
Nuvasive, Inc.·00887517177438·VuePoint Cross Conn, 3.5x44mm Fixed Rod
MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
LOUSEBUSTER
FDA 510(k)
FDA Class 1
·General Hospital
METRX II
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code LXH·April 16, 2026
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 29, 2016
SUCTION APPARATUS, PATIENT CARE
FDA Adverse Event
EMG TECHNOLOGY CO. LTD·Product code DWM·June 30, 2014
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 17, 2010
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 2, 2013
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
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024