33 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
FDA Recall
Open, Classified
·INCIPIO DEVICES avenue des Paquiers 16 St-Blaise Switzerland·Product code HWA·October 30, 2024
Exactech Ergo Impactor Handle, Catalog #321-09-05.
FDA Recall
Open, Classified
·Exactech, Inc.·Product code HWA·June 5, 2023
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
FDA Recall
Open, Classified
·Exactech, Inc.·Product code HWA·February 3, 2026
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
FDA Recall
Open, Classified
·Exactech, Inc.·Product code HWA·February 3, 2026
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
FDA Recall
Open, Classified
·PYRAMES INC·Product code DXN·February 24, 2025
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
FDA Recall
Open, Classified
·GE MEDICAL SYSTEMS, ISRAEL LTD. Nativ Haa??or Street no.·Product code IYN·September 6, 2023
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
FDA Recall
Open, Classified
·Visgeneer, Inc.
No. 335 Zhong Hua Rd., Sec. 6
Xiangshan Dist.
Hsinchu City Taiwan·Product code PTC·October 4, 2023
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
FDA Recall
Open, Classified
·Visgeneer, Inc.
No. 335 Zhong Hua Rd., Sec. 6
Xiangshan Dist.
Hsinchu City Taiwan·Product code PTC·October 4, 2023
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube.
FDA Recall
Open, Classified
·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code HAW·March 15, 2024
Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
FDA Recall
Open, Classified
·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWA·March 3, 2021
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585
FDA Recall
Open, Classified
·Medtronic Navigation, Inc.·Product code HAW·November 11, 2021
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
FDA Recall
Open, Classified
·Medtronic Navigation, Inc.·Product code HAW·April 11, 2023
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.
FDA Recall
Open, Classified
·Medtronic Navigation, Inc.·Product code HAW·September 27, 2023
Brand Name: Leksell Vantage Arc System REF: 1053958
FDA Recall
Open, Classified
·Elekta, Inc.·Product code HAW·March 19, 2026
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
FDA Recall
Open, Classified
·Navinetics Inc·Product code HAW·February 26, 2024
Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S
FDA Recall
Open, Classified
·Globus Medical, Inc.·Product code HAW·December 11, 2023
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evacuator Kit; (4) Part #A2200-01, Salcman Twist Drill Kit I; (5) Part #907801, Insertion Cannula Kit; (6) Part #50398-01, Catheter Inserter Needle 1,5; (7) Part #307165, Insertion Cannula 190 MM; (8) Part #60377-02, Twist Drill 3.2 MM; (9) Part #60377-01, Twist Drill 2.1 MM; (10) Part #50376-01, Salcman Twist Drill 2.1/3.2; (11) Part #14001050, Catheter Inserter Needle 2,6; and (12) Part #1002248, Frame G w Straight/Curved Front.
FDA Recall
Open, Classified
·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code HAW·March 1, 2023
Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S
FDA Recall
Open, Classified
·Globus Medical, Inc.·Product code HAW·December 11, 2023
Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
FDA Recall
Open, Classified
·Elekta, Inc.·Product code HAW·September 30, 2025