13 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
FDA 510(k)
FDA Class 2
·Microbiology
Biomet® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868308918·
BIOMET HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304256323·
Sklar
FDA UDI
SKLAR CORPORATION·10649111398742·TC KELLY SCISS CVD 6 1/4 INCHES
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A163626120·16mm H x 36mm W x 26mm L x 12 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A16362680·16mm H x 36mm W x 26mm L x 8 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A163626150·16mm H x 36mm W x 26mm L x 15 degrees ALIF
DURAFLEX
FDA 510(k)
FDA Class 2
·Dental
CUTERA GENESISPLUS LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 11, 2013
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·June 10, 2011
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·September 2, 2008
Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNTEL RT-EMB; A4408, 7F-80CM, SYNTEL RT-EMB; A4F00, 2F-60CM (PREM) SYNTEL CATHETER; A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; CE0260ST, L2F-60CM PREM SYNTEL CATH; CE0280ST, L2F-80CM PREM SYNTEL CATH; CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; CE0380ST, 3F-80CM PREM SYNTEL CATH; CE0440ST, 4F-40CM PREM SYNTEL CATH; CE0480ST, 4F-80CM PREM SYNTEL CATH; CE0580ST, 5F-80CM PREM SYNTEL CATH; CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; CE0780ST, 7F-80CM PREM SYNTEL CATH; CE0340, 3F-40cm, SYNTEL RT-EMB; CE0380, 3F-80cm, SYNTEL RT-EMB; CE0440, 4F-40cm, SYNTEL RT-EMB; CE0480, 4F-80cm, SYNTEL RT-EMB; CE0580, 5F-80cm, SYNTEL RT-EMB; CE0680, 6F-80cm, SYNTEL RT-EMB; CE0780, 7F-80cm SYNTEL RT-EMB. BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·October 3, 2012