13 results
·
36ms
·
Sources: EU EUDAMED, US FDA
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
FDA 510(k)
FDA Class 2
·Anesthesiology
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604862·BERCHTOLD B810, B710 4" SOFTCARE
Clear Readers
FDA UDI
Diversified Products, Inc.·00842894127230·
n/a
FDA UDI
Ortho Development Corporation·00822409075294·Distal Reamer 17.5mm
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 3, 2025
MICROLIGHT 830 LASER SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
HARDYDISK TICARILLIN 75MCG
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2024
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·April 26, 2013
SOFT ACT/SOFT-SENSE
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC, USA·Product code NBW·July 21, 2008
PENUMBRA COIL 400 DETACHMENT HANDLE
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·April 7, 2011
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·April 1, 2013
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014