11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
GOMCO CIRCUMCISION CLAMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LM- LAP 10 HIGH FLOW INSUFFLATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 13, 2013
SYBRONPRO XRT
FDA Adverse Event
Injury
·EBI INC.·Product code DZE·February 16, 2011
ENDEAVOR RESOLUTE RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·August 8, 2014
JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·March 15, 2023
JAWS "HIQ+", 5 X 330 MM, SCISSORS, METZENBAUM
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·March 30, 2023
SHAFT "HIQ+", 5 X 330 MM
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·May 23, 2023
JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·March 15, 2023
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020