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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.
FDA Enforcement
Class II
·Ongoing·Hologic, Inc·October 12, 2022
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
FDA Enforcement
Class II
·Ongoing·Echonous Inc·July 17, 2024
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
FDA Enforcement
Class II
·Ongoing·REPLIGEN CORPORATION·January 21, 2026
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·May 25, 2022
Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
FDA Enforcement
Class II
·Ongoing·Cardinal Health·December 14, 2022
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
FDA Enforcement
Class I
·Ongoing·Centerline Biomedical Inc·May 28, 2025
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·July 9, 2025
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
FDA Enforcement
Class II
·Ongoing·Medtronic Neuromodulation·June 1, 2022
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO
FDA Enforcement
Class II
·Ongoing·Scholly Fiberoptic Gmbh·August 16, 2023
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
FDA Enforcement
Class II
·Ongoing·WANDERCRAFT SAS·May 14, 2025
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·July 2, 2025
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·January 24, 2024
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient
FDA Enforcement
Class II
·Ongoing·Cardinal Health·December 14, 2022
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient
FDA Enforcement
Class II
·Ongoing·Cardinal Health·December 14, 2022
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient
FDA Enforcement
Class II
·Ongoing·Cardinal Health·December 14, 2022
MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·March 27, 2024