24 results
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49ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GILES SCIENTIFIC INC
FDA registration
GILES SCIENTIFIC INC·1 product·🇺🇸 United States
BIOMIC
FDA UDI
Giles Scientific, Inc.·00863504000217·
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
FDA Enforcement
Class II
·Terminated·NEO METRICS, INC.·June 18, 2014
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
FDA Recall
Terminated
·NEO METRICS, INC.·Product code OCY·March 31, 2014
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
FDA Recall
Open, Classified
·Oxoid Limited Wade Road Basingstoke United Kingdom·Product code JTN·December 23, 2024
Blood/MacConkey Biplate 100/PK, Product Number R02049
FDA Recall
Open, Classified
·Remel, Inc·Product code JSI·July 11, 2025
Blood/EMB, Levine 100/PK, Product Number R02041
FDA Recall
Open, Classified
·Remel, Inc·Product code JSI·July 11, 2025
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
FDA Recall
Open, Classified
·Remel, Inc·Product code JSH·July 11, 2025
Strep Selective II Agar, Product Number R01859
FDA Recall
Open, Classified
·Remel, Inc·Product code JSI·July 11, 2025
CORAIL HIGH OFFSET STEM Collarless SIZE 14
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code KWL·July 12, 2017
CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code KWL·July 12, 2017