66 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code FKX·December 15, 2015
Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.
FDA Recall
Terminated
·Ecolab Inc·Product code KKX·November 30, 2016
American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and to cover non-exudating wounds and for use as a secondary dressing for fixation of catheters or cannulae.film, 10cm x 12.5 cm, Paul Hartmann AG, 89522 Heidenhiem, Germany
FDA Recall
Terminated
·Hartmann USA, Inc·Product code MGP·February 11, 2011
American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017
American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 16, 2015
American Surgical Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016