8 results
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26ms
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Sources: EU EUDAMED, US FDA
BIOMERIEUX HEMOLAB COFAC X
FDA 510(k)
FDA Class 2
·Hematology
STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED
FDA 510(k)
FDA Class 2
·General Hospital
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
FDA 510(k)
FDA Class 1
·Microbiology
HEARTSTRING III PROXIMAL SEAL SYSTEM, 4.3 MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·December 3, 2010
DFS2
FDA Adverse Event
Other
·ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB·Product code FNM·January 22, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 15, 2014
Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.
FDA Enforcement
Class I
·Terminated·Cook Inc.·August 31, 2016
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag Spike w ChemoLock Port/CL2150; 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger/CL3011; 9 IN(23cm)APPX 2.7ml,EXT SET,ChemoLock PORT,2 CLAMPS,2 GRADUATED CONN/CL3364; Syringe Transfer Set w Clave, ChemoLock Port/CL-34; 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, ChemoLock w Red Cap, Bag Hanger/CL3511; 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, ChemoLock w Red Cap, Bag Hanger/CL3511T; 30" (76cm) Appx 6.3 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock w Red Cap, Hanger/CL3528; 7" (18 cm) Appx .93 ml, Ext Set w/ChemoLock, Y-Connector, Rotating Luer/CL3535T; Oncology Kit w/5" (13 cm) Add-On Set w ChemoLock Additive Port, Vented Cap, ChemoLock, Spinning Spiros w Red Cap/CL3538; Graduated Connector w ChemoLock Port/CL3900; ONCOLOGY KIT, EXT,ChemoLock PORT, GRAD CONN,TRANSFER,ChemoLock,VIAL SPIKE,ChemoLock PORT/CL3927; Oncology Kit w 5" (13 cm) Add-On Set w ChemoLock w Red Cap, Vented Cap, ChemoLock Port w Bag Spike, Spiros w Red Cap/CL3946; Oncology Kit w 17" (43 cm) Bifuse Ext Set w/ChemoLock w Red Cap, ChemoLock Port, ChemoLock Vented Vial Spike, 13mm ChemoLock/CL3947; Oncology Kit w ChemoLock Port Closed Vial Spike, ChemoLock, ChemoLock Port Bag Spike/CL3952; APPX 0.5ml, ChemoLock BAG SPIKE WITH ADDITIVE PORT,ChemoLock Port/CL3955;
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·September 14, 2022