44 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 29, 2015
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
FDA Enforcement
Class II
·Ongoing·DJO, LLC·December 3, 2025
Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 6, 2013
T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·May 2, 2018
T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·May 2, 2018
T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·May 2, 2018
Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
FDA Enforcement
Class II
·Terminated·Breg Inc·May 10, 2017
Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·April 24, 2013
Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 12, 2014
Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·December 18, 2024
ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·March 31, 2021
AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020