14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CPAP Cannulaide
FDA 510(k)
FDA Class 2
·Anesthesiology
V. Mueller
FDA UDI
STERIS CORPORATION·10885403279249·V. Mueller DISPOSABLE BIPOLAR FORCEPS
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702253719·E2/AG/SL-OT-E/OH-WOV-ZI/BL
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702563283·ELVAREX 2/KNEE HIGH/SLANT-CLOSED TOE/CRANBERRY
ENDOSKELETON® TCS
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00191375032045·Rigid Container System Tray, Upper
ESSENTIAL MRI PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
VIAVALVE SAFETY IV CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
ACCU-CHEK ® AVIVA COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·October 6, 2014
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013
SYMBIA T, T2, T6, T16
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA INC. MI GROUP·Product code IYX·May 9, 2011
EAGLE EYE PLATINUM SHORT TIP
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. 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