9 results
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17ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
Xcaliber Bone Screws
FDA UDI
ORTHOFIX SRL·18054242511144·SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT ...
Xcaliber Bone Screws
FDA UDI
ORTHOFIX SRL·18054242512134·SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D...
FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED
FDA 510(k)
FDA Class 1
·Dental
UNKNOWN DEPUY PINNACLE 36MM +4 10D LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·December 30, 2010
MEGA NEEDLE DRIVER
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·February 6, 2013
RESTORATION ADM X3 INS 28/54
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·July 21, 2014
PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558. 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