38 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
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
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
FDA Enforcement
Class II
·Ongoing·Wright Medical Technology, Inc.·July 6, 2022
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
FDA Enforcement
Class II
·Ongoing·Wright Medical Technology, Inc.·April 10, 2024
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
FDA Enforcement
Class II
·Ongoing·Stryker Instruments·August 3, 2022
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits will be assembled using Medline and other manufacturers medical device components and drug components in some cases. Customers specify the kit contents, quantity, and placement of individual items in the kit.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 3, 2025
MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·November 26, 2025
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures.
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·April 7, 2021
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·November 26, 2025
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·November 26, 2025
MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·November 26, 2025
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·November 26, 2025
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·December 31, 2025