156 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
FDA Enforcement
Class II
·Ongoing·New Standard Device Inc·September 7, 2022
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.
FDA Enforcement
Class II
·Ongoing·Medtronic Navigation, Inc.·February 5, 2025
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
FDA Enforcement
Class II
·Ongoing·Wright Medical Technology, Inc.·July 12, 2023
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
FDA Enforcement
Class II
·Ongoing·Medtronic Navigation, Inc.·January 17, 2024
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
FDA Enforcement
Class II
·Ongoing·Medtronic Navigation, Inc.·January 17, 2024
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
FDA Enforcement
Class II
·Ongoing·Medtronic Neuromodulation·August 4, 2021
Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741
FDA Enforcement
Class II
·Ongoing·Coltene Whaledent Inc·May 5, 2021
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·January 22, 2025
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
FDA Enforcement
Class II
·Ongoing·Think Surgical, Inc.·March 27, 2024
One Step P in vitro diagnostic test REF: 8194
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve plus a locking mechanism. Product design features an easy release mechanism. Available with or without a titanium pyramid. The lanyard is part of the Alpha Interlock" Suspension System. This system allows you to interchange suspension methods without remaking a socket Model, 3 part numbers - 700-AIS100, Alpha Interlock Suspension System with Alpha Lanyard - 700-AIS101, Alpha Interlock Suspension System with Alpha Lanyard w/Titanium Pyramid - 700-AIS107, Alpha Interlock Suspension System Lanyard Body ONLY
FDA Enforcement
Class II
·Ongoing·WillowWood Global Llc·May 26, 2021
STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001
FDA Enforcement
Class II
·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·December 21, 2022
Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.
FDA Enforcement
Class II
·Ongoing·Augmedics Ltd.·May 21, 2025
Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
FDA Enforcement
Class II
·Ongoing·Encore Medical, Lp·August 7, 2019
stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
FDA Enforcement
Class II
·Ongoing·Aesculap Inc·March 13, 2024
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
FDA Enforcement
Class II
·Ongoing·Aesculap Inc·March 13, 2024
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·April 13, 2022
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
FDA Enforcement
Class II
·Ongoing·Folsom Metal Products, Inc.·September 24, 2025
Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
FDA Enforcement
Class II
·Ongoing·Folsom Metal Products, Inc.·September 24, 2025