383 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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1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog Number: 5820-066-012
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·October 23, 2024
LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·February 5, 2020
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 1, 2026
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 14, 2022
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 1, 2026
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 1, 2026
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 1, 2026
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 1, 2026
Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 1, 2026
Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 1, 2026
Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
FDA Enforcement
Class II
·Ongoing·Aesculap Implant Systems LLC·May 17, 2023
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·June 18, 2025
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·June 18, 2025
Bodor's I series laser cutting machine.
FDA Enforcement
Class II
·Ongoing·Jinan Bodor Cnc Machine Co Ltd·July 30, 2025
CEI Cutting Edge Instruments (PTC-57C)
FDA Enforcement
Class II
·Ongoing·Coltene Whaledent Inc·November 25, 2020
ESG PK CUTTING FORCEPS, 5MM, 33CM
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·February 28, 2024
Bodor P and C series laser cutting machines
FDA Enforcement
Class II
·Ongoing·Jinan Bodor Cnc Machine Co Ltd·January 29, 2025
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 10, 2024
Astral 100 and Astral 150 ventilators
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·November 1, 2023