27 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Auxein Brand Vertaux 5.5 mm Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
UP - Vehicle - 380-55230 - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588014173·UP - Vehicle - 380-55230 - 18 Metal
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)
EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code FTM·May 27, 2015
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 10, 2011
Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
FDA Recall
Terminated
·Elcam Medical, Inc.·Product code FMG·February 2, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
ENDURON NEUT 56 OR 68ODX28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HRY·October 16, 2008
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 26, 2013
PERC. THROMBOLYTIC DEVICE KIT
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DXE·August 3, 2011
ONYX
FDA Adverse Event
Injury
·MEDTRONIC COVIDIEN·Product code MFE·April 18, 2017
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·April 22, 2015
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·April 22, 2015
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 6, 2012
ENDURANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·November 22, 2017
TALENT AAA STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·November 22, 2017
UNKNOWN EPOCA SHOULDER ARTHROPLASTY SYSTEM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSD·June 20, 2019
PROXIMATE*PPH PROCEDURE SET
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 27, 2018