8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REPLACE-A-TIP HIGH TEMP. CAUTERY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PTCA BALLOON CATHETERS & ACCESS.
FDA 510(k)ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 2, 2014
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 16, 2012
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·June 15, 2015
RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system.
FDA Recall
Terminated
·RenovoRx, Inc.·Product code MJN·November 25, 2015
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017