44 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DISPOSABLE HAND HELD NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
Aortic Valve Retractor
FDA UDI
KOROS U.S.A., INC.·10840199537249·Optional Aortic Valve Retractor 16mm wide
0800,IPS1,08,N,U,LT,AU,TV ON/OFF,ENTER
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828153270·0800,IPS1,08,N,U,LT,AU,TV ON/OFF,ENTER
LATITUDE ELBOW PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
PIPET CALIBRATION KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C Product Usage: The MaxPlus bifuse extension sets are used administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein.
FDA Recall
Terminated
·Carefusion 303, Inc.·Product code FPA·April 20, 2011
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 8, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 22, 2012
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·August 3, 2010
LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE GAUCHE
FDA Adverse Event
Injury
·TORNIER INC·Product code JDC·May 7, 2024
regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·October 14, 2015
regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015
Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Subs. C. R. Bard, Inc.·Product code GCJ·April 24, 2014
Bard Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Subs. C. R. Bard, Inc.·Product code GCJ·April 24, 2014
Bard Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Subs. C. R. Bard, Inc.·Product code GCJ·April 24, 2014
Bard Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Subs. C. R. Bard, Inc.·Product code GCJ·April 24, 2014
Bard Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Subs. C. R. Bard, Inc.·Product code GCJ·April 24, 2014
Bard Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Subs. C. R. Bard, Inc.·Product code GCJ·April 24, 2014
BardVentralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\ Catalog #0010302, lot number HUTL1283. The BardVentralex" Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric". It is intended for use in all forms of hernia repair requiring reinforcement with a non-absorbable support material
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·April 11, 2011
Bard Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Subs. C. R. Bard, Inc.·Product code GCJ·April 24, 2014