10 results
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23ms
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Sources: EU EUDAMED, US FDA
PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS
FDA 510(k)
FDA Class 1
·Dental
VENTRALIGHT
FDA UDI
Davol Inc.·00801741031663·Ventralight ST Mesh, 7" x 9" (17.8 cm x 22.9 cm...
CERYX PACEMAKER MODELS 114, 314 & 614
FDA 510(k)
FDA Class 3
·Cardiovascular
HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VENTRALIGHT ST MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·January 8, 2024
EYE SURGERY STRETCHER OBS 3/07
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·February 11, 2013
CURRENT PLUS DR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 24, 2014
Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·September 26, 2012
Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Subs. C. R. Bard, Inc.·Product code FTL·September 4, 2012