11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380
FDA 510(k)
FDA Class 2
·Anesthesiology
GEN-X 800/800
FDA 510(k)
FDA Class 1
·Radiology
DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD
FDA 510(k)
FDA Class 2
·Clinical Toxicology
STERLING¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·February 5, 2013
SYNERGY
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·December 6, 2010
OLYMPUS XENON SHORT-ARC LAMP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GCT·May 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
PKG, CLAW FORCEPS, P/N 0250080244. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014