238 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
Integra Cadence Total Ankle System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·January 20, 2017
Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)
FDA Recall
Terminated
·Medtronic Neurosurgery·Product code HBO·December 20, 2017
AUTO REF/KERATOMETER ARK-1s
FDA Recall
Terminated
·Nidek Inc.·Product code HKO·December 20, 2017
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FBN·December 20, 2017
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LDP·July 20, 2017
VITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
VITEK 2 Gram Negative Susceptibility card (AST-N339), IVD, REF 419341, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
VITEK 2 Gram Negative Susceptibility card (AST-N335), IVD, REF 418985, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
VITEK 2 Gram Negative Susceptibility card (AST-N249), REF 413572, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
VITEK 2 Gram Negative Susceptibility card (AST-N216), REF 413066, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
VITEK 2 Gram Negative Susceptibility card (AST-N329), IVD, REF 418631, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
VITEK 2 Gram Negative Susceptibility card (AST-N345), IVD, REF 420580, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
VITEK 2 Gram Negative Susceptibility card (AST-N209), REF 412938, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
VITEK 2 Gram Negative Susceptibility card (AST-N238), REF 413203, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
VITEK 2 Gram Positive Susceptibility card (AST-P634), IVD, REF 415671, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
VITEK 2 Gram Negative Susceptibility card (AST-N204), REF 412865, 20 cards per carton. .
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
VITEK 2 Gram Positive Susceptibility card (AST-P612), REF 22359, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
VITEK 2 Gram Negative Susceptibility card (AST-GN65), REF 412608, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
VITEK 2 Gram Positive Susceptibility card (AST-P638), IVD, REF 418423, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017