7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUPRASSON P MAX
FDA 510(k)
FDA Class 2
·Dental
SMR 40MM GLENOSPHERE
FDA 510(k)
FDA Class 2
·Orthopedic
VISULAS YAG III
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENVISTA INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·BAUSCH & LOMB INCORPORATED·Product code HQL·July 23, 2015
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 17, 2014
LINOX SMART SD 65/16
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·December 27, 2012
PKG, BABCOCK FORCEPS, PADDLE, P/N 0250080250. 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