83 results
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54ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement.
FDA Enforcement
Class II
·Terminated·Signal Medical Corporation·October 29, 2014
Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement.
FDA Recall
Terminated
·Signal Medical Corporation·Product code LPH·September 23, 2014
ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.
FDA Recall
Terminated
·Hummingbird Med·Product code KST·March 11, 2015
AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597013; 4) AngioDynamics 5F Standard Micro- Introducer Kit, Sterile, Catalog Number: 06597018; and 5) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597019. Product kits are individually wrapped in plastic, 10 units included per box. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code DQR·April 30, 2013
Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA7-05SD - 0.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012