146 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·November 5, 2014
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·November 5, 2014
ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·November 5, 2014
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
FDA Enforcement
Class II
·Terminated·Epocal·August 21, 2013
Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
FDA Enforcement
Class I
·Terminated·C.L.R. Medicals International, Inc.·January 1, 2014
Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 15, 2013
Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·October 19, 2016
Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
FDA Recall
Terminated
·Asante Solutions, Inc.·Product code FPA·November 19, 2013
Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
FDA Recall
Terminated
·Asante Solutions, Inc.·Product code FPA·November 19, 2013
Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
FDA Recall
Terminated
·Asante Solutions, Inc.·Product code FPA·November 19, 2013
Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark
FDA Recall
Terminated
·Asante Solutions, Inc.·Product code FPA·November 19, 2013
Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
FDA Recall
Terminated
·Asante Solutions, Inc.·Product code FPA·November 19, 2013
Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
FDA Recall
Terminated
·Asante Solutions, Inc.·Product code FPA·November 19, 2013
Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
FDA Recall
Terminated
·Asante Solutions, Inc.·Product code FPA·November 19, 2013
Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
FDA Recall
Terminated
·Asante Solutions, Inc.·Product code FPA·November 19, 2013
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Recall
Terminated
·Clorox Healthcare Holdings, LLC (dba HealthLink)
3611 Saint Johns Bluff Rd S Ste 1
Suite 1
Jacksonville FL 32224-2679·Product code LRY·March 18, 2013
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Recall
Terminated
·Clorox Healthcare Holdings, LLC (dba HealthLink)
3611 Saint Johns Bluff Rd S Ste 1
Suite 1
Jacksonville FL 32224-2679·Product code LRY·March 18, 2013
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Recall
Terminated
·Clorox Healthcare Holdings, LLC (dba HealthLink)
3611 Saint Johns Bluff Rd S Ste 1
Suite 1
Jacksonville FL 32224-2679·Product code LRY·March 18, 2013