27 results · 24ms · Sources: EU EUDAMED, 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