13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ROCCIA® MultiLIF
FDA 510(k)
FDA Class 2
·Orthopedic
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293401·
GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L
FDA 510(k)
FDA Class 2
·Radiology
AUDIT MICROCV PROCALCITONIN LINEARITY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606151924·17 X 14 CERVICAL TRIALS 34MM 0° LORDOSIS
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606152112·17 X 14 CERVICAL TRIALS 34MM 10° LORDOSIS
INTERJECT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCG·May 27, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 14, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
HUDSON HVT ISIS ENDOTRACHEAL CUFF TUBE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·June 29, 2011
HAART 200 AORTIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·CORCYM INC.·Product code KRH·May 8, 2025
HAART 200 AORTIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·CORCYM INC.·Product code KRH·May 9, 2025
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021