3,111 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUPRAMID EXTRA
FDA UDI
S JACKSON INC·00816848020700·3/8 Circle Reverse Cutting Needle (24.3mm), USP...
entre
FDA UDI
Tactile Systems Technology, Inc.·00816305020038·Entré/Entre Plus Half Leg - PD08-U
Humeral Fixation Set
FDA UDI
SKELETAL DYNAMICS L.L.C.·00841506129327·
Humeral Plating System
FDA UDI
SKELETAL DYNAMICS L.L.C.·00841506110073·
Humeral Plating System
FDA UDI
SKELETAL DYNAMICS L.L.C.·00841506110035·
Humeral Fixation Set
FDA UDI
SKELETAL DYNAMICS L.L.C.·00841506129303·
Humeral Plating System
FDA UDI
SKELETAL DYNAMICS L.L.C.·00841506110097·
Humeral Fixation Set
FDA UDI
SKELETAL DYNAMICS L.L.C.·00841506129280·
Humeral Fixation Set
FDA UDI
SKELETAL DYNAMICS L.L.C.·00841506129341·
Humeral Plating System
FDA UDI
SKELETAL DYNAMICS L.L.C.·00841506110059·
entre
FDA UDI
Tactile Systems Technology, Inc.·00816305021646·
SENSATION PLUS 8FR. 50CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DSP·November 10, 2017
LC PCA HOSPIRA MEDNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·January 14, 2013
LIFELINE
FDA Adverse Event
Malfunction
·DEFIBTECH, L.L.C.·Product code MKJ·November 14, 2024
LC PCA HOSPIRA MEDNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·October 6, 2011
LC PCA HOSPIRA MEDNE
FDA Adverse Event
Injury
·HOSPIRA COSTA RICA LTD.·Product code MEA·January 14, 2013
HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.
FDA Enforcement
Class III
·Terminated·Smiths Medical ASD, Inc.·February 15, 2017
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 28, 2026
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 28, 2026
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 28, 2026