12 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Soehendra Stent Retriever
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOEHENDRA STENT RETRIEVER
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 26, 2017
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994152428·INSTRUMENT 8161203 TWO PRNG SMA STPL TRL
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813834·GENUMEDI PRO SILVER SIZE III
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 19, 2022
ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TINA-QUANT ALBUMIN GEN 2
FDA 510(k)
FDA Class 2
·Immunology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
VENTAK PRIZM
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 13, 2011
PLUM A+ PUMP
FDA Adverse Event
Injury
·HOSPIRA, INC.·Product code FRN·September 15, 2008
OXF UNI PH3 FEMORAL IMPACTOR
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code HWA·November 1, 2018
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017