104 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VT·One, VT·One 60days
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Accufuse Cervical System
FDA UDI
ABSOLUTE ADVANTAGE MEDICAL, LLC·00810016801344·Cervical PEEK 16mmx14mmx10mm 7° Lordosis
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902758102·INSTRUMENT 8161410 4PRNG 10MM S STPL TRL
Ti3D CERVICAL
FDA UDI
XENIX MEDICAL LLC·00818345020962·CERVICAL CAGE 16W x 14D x10H, 6 DEG
MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2013
NUVASIVE LONG LATERAL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT
FDA 510(k)
FDA Class 2
·Dental
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376518329·12 mm CORE ENDPLATE, TRP 16 x 14 mm 10°
Compression Staple System
FDA UDI
TORNIER, INC.·00846832058730·Staple
Omnia Medical TiBrid™-SC
FDA UDI
OMNIA MEDICAL, LLC·00843511104221·TiBrid™-SC ASSEMBLY, 16.5x14.5x10mm
Unison®-C Anterior Cervical Fixation System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468082482·Interbody Fusion Device, 16mm (W), 14mm (D), 10...
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076330211·3D Porous Titanium Cervical Interbody, 16x14mm,...
Unison®-C Anterior Cervical Fixation System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468082550·Interbody Fusion Device, 16mm (W), 14mm (D), 10...
ShurFit ACIF 2C
FDA UDI
PRECISION SPINE, INC.·00840019921343·ACIF Trial, 16 x 14 x 10
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076330532·3D Porous Titanium Cervical Interbody, 16x14mm,...
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076331553·Rasp, 16x14mm, 10mm height, 6-degree
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076331225·Trial, 16x14mm, 10mm height, 6-degree
Flux-C Cervical Interbody
FDA UDI
Ulrich Medical Usa, Inc.·00810076330907·Trial, 16x14mm, 10mm height,
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 11, 2013
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 13, 2011