11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TOTAL COMPRESSION PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01; 3) List Number 43025-01; 4) List Number 43025-11; 5) List Number 43025-21; 6) List Number 43025-25; 7) List Number 43038-05; 8) List Number 43043-01; 9) List Number 43044-01; 10) List Number 43044-11; 11) List Number 43046-01; 12) List Number 43047-01; 13) List Number 43041-01; 14) List Number 43024-01; 15) List Number 43027-01; 16) List Number 43027-14; 17) List Number 43001-01; 18) List Number 43064-01; 19) List Number 43046-05; 20) List Number 43042-11; 21) List Number 43042-01; 22) List Number 43044-05; 23) List Number 43044-15
FDA Enforcement
Class II
·Terminated·Hospira Inc.·August 24, 2016
LEONE SPA
FDA UDI
LEONE SPA·08033707011835·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 25
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1430210·Rod Template, 500mm
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1430200·Rod Template, 250mm
SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250
FDA 510(k)
FDA Class 2
·Radiology
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNKNOWN PARIETENE MESH PRODUCT
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·October 6, 2014
GORE TRI-LOBE BALLOON CATHETER
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·May 23, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 23, 2011
LOGIC FEMORAL PS CEM LEFT SZ 4
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 13, 2023