1,512 results
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25ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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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
EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.
FDA Enforcement
Class I
·Ongoing·AMTEC SALES Inc·September 29, 2021
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
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-N4-36-109-36U 28-N4-36-154-32U 28-N4-36-154-36U 28-N4-36-199-32U 28-N4-36-199-36U 28-N4-36-259-36U 28-N4-38-109-38U 28-N4-38-154-34U 28-N4-38-154-38U 28-N4-38-199-34U 28-N4-38-199-38U 28-N4-38-259-38U 28-N4-40-114-40U 28-N4-40-154-36U 28-N4-40-154-40U 28-N4-40-204-36U 28-N4-40-204-40U 28-N4-40-259-40U 28-N4-42-114-42U 28-N4-42-159-38U 28-N4-42-159-42U 28-N4-42-204-38U 28-N4-42-204-42U 28-N4-42-259-42U 28-N4-44-114-44U 28-N4-44-164-40U 28-N4-44-164-44U 28-N4-44-209-40U 28-N4-44-209-44U 28-N4-44-259-40U 28-N4-44-259-44U 28-N4-46-114-46U 28-N4-46-164-42U 28-N4-46-164-46U 28-N4-46-209-42U 28-N4-46-209-46U 28-N4-46-259-42U
FDA Enforcement
Class I
·Ongoing·Bolton Medical Inc.·June 3, 2026