16 results
·
28ms
·
Sources: EU EUDAMED, US FDA
PROBE
FDA 510(k)
FDA Class 1
·Orthopedic
DSQ Alert Candida auris Primer Mix ASR
FDA UDI
Elitechgroup Mdx LLC·03661540952531·DSQ Alert™ Candida auris Primer Mix ASR is an a...
ACUMED
FDA UDI
Acumed LLC·10806378044328·VDR Plate Positioning Handle Assembly
ST JUDE MEDICAL
FDA Adverse Event
Injury
·ST JUDE MEDICAL·Product code MGB·March 22, 2017
HydroCision SpineJet System
FDA 510(k)
FDA Class 2
·Orthopedic
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
FDA 510(k)
FDA Class 2
·Cardiovascular
T8 STICK FIT HEXALOBE DRIVER
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·July 19, 2024
SCREW, FIXATION, BONE
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code HWC·July 19, 2024
CORAIL2 STD SIZE 9
FDA Adverse Event
Injury
·3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code KWY·May 8, 2014
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 22, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 7, 2007
Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e., recording and stimulation only. The device is designed to obtain electrograms in the atrial regions of the heart.
FDA Recall
Terminated
·Biosense Webster Inc·Product code DRF·March 25, 2008
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
FDA Recall
Terminated
·Greatbatch Medical·Product code DYB·November 12, 2012
Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e., recording and stimulation only. The device is designed to obtain electrograms in the atrial regions of the heart. 20 Poles, US Catalog Number D7L202515RT, EU Catalog Number 35T2515R
FDA Recall
Terminated
·Biosense Webster Inc·Product code DRF·March 25, 2008
The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on.
FDA Recall
Terminated
·Summit Industries Inc.·Product code IYB·October 28, 2014
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart. Including the left side of the heart through the interatrial septum.
FDA Recall
Terminated
·Greatbatch Medical·Product code DYB·September 24, 2012