37 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
FDA Recall
Open, Classified
·Keystone Industries·Product code MQC·November 20, 2023
KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
FDA Recall
Open, Classified
·Straumann USA LLC·Product code MQC·June 25, 2021
Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel
FDA Recall
Open, Classified
·Mac Medical Supply Co Inc·Product code ITX·August 4, 2021
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.
FDA Recall
Open, Classified
·Dutch Ophthalmic USA, Inc.·Product code HQC·May 21, 2019
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision Inc·Product code HQC·April 6, 2022
Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision, Inc.·Product code HQC·March 14, 2024
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC·Product code HQC·April 28, 2025
Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024
Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024
Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024
Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024
Constellation Procedure Pak
FDA Recall
Open, Classified
·Alcon Research, LTD.·Product code HQC·June 28, 2023
Centurion FMS Pak
FDA Recall
Open, Classified
·Alcon Research, LTD.·Product code HQC·June 28, 2023
Alcon Custom Pak
FDA Recall
Open, Classified
·Alcon Research, LTD.·Product code HQC·June 28, 2023
Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
FDA Recall
Open, Classified
·D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands·Product code HQC·January 15, 2024
Constellation Vision System, REF: 8065751150
FDA Recall
Open, Classified
·Alcon Research, LLC·Product code HQC·August 18, 2023
Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024
Single-Use Packs, REF: OPO80
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision, Inc.·Product code HQC·December 7, 2022
Legion FMS Pak
FDA Recall
Open, Classified
·Alcon Research, LTD.·Product code HQC·June 28, 2023
Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision, Inc.·Product code HQC·September 1, 2022