11 results
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20ms
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Sources: EU EUDAMED, US FDA
eCligner
FDA 510(k)
FDA Class 2
·Dental
A SCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
FDA 510(k)
FDA Class 1
·General Hospital
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·October 30, 2023
4.5MM TI CORTEX SCREW SELF-TAPPING 46MM
FDA Adverse Event
Injury
·SYNTHES GRENCHEN·Product code HWC·October 6, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
AFFINITY BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code HDD·June 2, 2011
IFUSE IMPLANT SYSTEM
FDA Adverse Event
Injury
·SI-BONE, INC.·Product code OUR·August 12, 2014
AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE
FDA Adverse Event
Injury
·CONMED UTICA·Product code GEI·May 18, 2023
AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·May 25, 2023
PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080264. 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