9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LT-300 Video Colposcope
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AMELOGEN PLUS
FDA 510(k)
FDA Class 2
·Dental
BILLY BOY MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 1, 2014
BIOSYN 3/0 27 UNDYED C-14
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL·Product code GAM·May 24, 2013
ONESTEP
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 30, 2014
ACCU-CHEK ® INFORM METER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·June 28, 2011
ELECSYS PROLACTIN ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CFT·February 26, 2021
PKG, 5MM X 33CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250080757 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