1,258 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E; Loaner, Arctic Sun M5000, NA/5000-00-00L; Arctic Sun 5000, EU/5000-1-01; Loaner, Arctic Sun M5000, EU/5000-01-01L; Arctic Sun 5000, UK/5000-01-02; Arctic Sun 5000, Australia/5000-01-03; Arctic Sun 5000, China/5000-01-04; Arctic Sun 5000, Brazil/5000-01-05; Arctic Sun 5000, Switzerland/5000-01-07; Arctic Sun 5000, South Africa/5000-01-08
FDA Enforcement
Class II
·Ongoing·Medivance Inc.·August 7, 2024
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
FDA Enforcement
Class II
·Ongoing·Medivance Inc.·April 3, 2024
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Component: No
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Plum Duo Precision IV Pump, 40002-0403
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·June 17, 2026
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Halyard, Drape Pack. Kit Code: LMDP36-01.
FDA Enforcement
Class II
·Ongoing·AVID Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Plum Duo Infusion Pump, 40002-0401
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·June 17, 2026
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
FDA Enforcement
Class II
·Ongoing·AVID Medical, Inc.·June 17, 2026
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026