9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TRACHEAL TUBE, REINFORCED, CUFFED
FDA 510(k)
FDA Class 2
·Anesthesiology
LYSTA HYGIENIST III SCALER
FDA 510(k)
FDA Class 2
·Dental
APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES
FDA Adverse Event
Injury
·3M UNITEK·Product code DYH·May 9, 2012
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·December 6, 2010
AUTOPULSE NIMH BATTERY
FDA Adverse Event
ZOLL CIRCULATION, INC.·Product code DRM·January 29, 2013
CROSSBOSS CATHETER
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·July 18, 2014
MENTOR MEMORYGEL BOOST BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·November 13, 2025
PKG, GRASPER FORCEP, BOWEL, P/N 0250080324. 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