37 results · 12ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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