10 results
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19ms
·
Sources: EU EUDAMED, US FDA
VANADIUM EXCAVATORS SIZES 0-6
FDA 510(k)
FDA Class 1
·Dental
NA
FDA UDI
Richard Wolf GmbH·04055207043318·RECTOSCOPE TUBE Ø 19MM WL 311MM WL 311mm, TL 3...
AGILE NAIL
FDA UDI
ORTHOFIX SRL·18056099648943·AGILE NAIL TI LOCKING SCREW L55MM D4MM STERILE
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADX4000W
FDA 510(k)
FDA Class 2
·Dental
TOTAL ASR ACET IMP SIZE 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 27, 2014
LASSO® 2515 NAV ECO VARIABLE CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·November 15, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 14, 2010
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·August 14, 2019
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018