13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CAAS A-Valve
FDA 510(k)
FDA Class 2
·Radiology
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
ANTI-I.V. ENTERAL FEEDING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
MARYLAND BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 3, 2013
PENUMBRA SYSTEM REPERFUSION CATHETER 032
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·June 23, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·December 22, 2023
BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·August 14, 2019