30 results
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21ms
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Sources: EU EUDAMED, US FDA
HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
FDA Enforcement
Class II
·Terminated·Hardy Diagnostics·September 2, 2015
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
Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
FDA Enforcement
Class I
·Terminated·Siemens Healthcare Diagnostics, Inc.·November 19, 2014
American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 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 Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S 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 Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 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 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Enforcement
Class II
·Terminated·American Surgical Company·June 1, 2016
Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
FDA Enforcement
Class II
·Terminated·Zipline Medical·March 11, 2015