7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ECHOFLOW DOPPLER BLOOD VELOCITY METER
FDA 510(k)
FDA Class 2
·Cardiovascular
LEY ELECTRO-SURGICAL UNITS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VZV MICROASSAY
FDA 510(k)
FDA Class 2
·Microbiology
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITJ·March 5, 2013
SINGLE 8 EXTENSION
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIV·Product code LGW·February 8, 2011
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 SN012 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 12x12x12 UDI-DI Code: 00817906020090 T50 SN020 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 20x20x20 UDI-DI Code: 00817906020151 T50 SN110 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x15x13 UDI-DI Code: 00817906020113 T50 SN115 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 15Wx15x15 UDI-DI Code: 00817906020137 T50 SN118 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 18x14x14 UDI-DI Code: 00810021861364 Single/multiple component metallic bone fixation appliances and accessories The In2Bones USA NeoSpan" Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.
FDA Enforcement
Class II
·Ongoing·In2bones USA, LLC·June 17, 2026