13 results · 36ms · Sources: EU EUDAMED, US FDA

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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