10 results
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18ms
·
Sources: EU EUDAMED, US FDA
MTB 1043 TREATMENT BOOTH
FDA 510(k)
FDA Class 2
·General Hospital
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704267181·
Crea Calibration Solution 1
FDA UDI
Radiometer Medical ApS·05700699441331·S1827 Crea Calibration Solution 1, membrane bot...
CLEANSE N BOND I
FDA 510(k)
FDA Class 2
·Dental
DISPOSABLE FLUID COLLECTION BAG
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
B1005, ACUCISE ENDOPYELOTOMY SYSTEM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 5, 2013
FIBER ONE
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·December 29, 2010
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2014