12 results · 36ms · Sources: EU EUDAMED, 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