10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
INSULIN AUTOPAK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Cortical Fixation Systems
FDA 510(k)
FDA Class 2
·Orthopedic
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0
FDA 510(k)
FDA Class 2
·Anesthesiology
VDW.ROTATE 15.04 6-FILES 25MM
FDA Adverse Event
Malfunction
·VDW GMBH·Product code EKS·January 27, 2023
VDW.ROTATE 15.04 6-FILES 25MM
FDA Adverse Event
Malfunction
·VDW GMBH·Product code EKS·November 9, 2023
MONOCRYL (POLIGLECAPRONE 25) SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAN·April 30, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·October 10, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 29, 2010
12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·September 12, 2019
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017