15 results
·
28ms
·
Sources: EU EUDAMED, US FDA
IGUIDE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
GEODESIC EEG SYSTEM, MODEL 200
FDA 510(k)
FDA Class 2
·Neurology
MULTI-FUNCTION DEFIBRILLATION ELECTRODE
FDA 510(k)
FDA Class 3
·Cardiovascular
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857184107·Lordotic Trial, Size 24x30x15 mm, 5°
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857184084·Lordotic Trial, Size 24x30x11 mm, 5°
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857184091·Lordotic Trial, Size 24x30x13 mm, 5°
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857184121·Lordotic Trial, Size 24x30x19 mm, 5°
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857184138·Lordotic Trial, Size 24x30x21 mm, 5°
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857184077·Lordotic Trial, Size 24x30x9 mm, 5°
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857184114·Lordotic Trial, Size 24x30x17 mm, 5°
WAVEWRITER ALPHA PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 19, 2023
REACH J&J FLOSS CLEAN BURST SPEARMINT
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON CONSUMER PRODUCTS·Product code JES·April 23, 2013
TOTALCARE BARIATRIC
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 21, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014