22 results · 24ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005

FDA Enforcement
Class II ·Ongoing·Stryker Corporation·November 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005

FDA Enforcement
Class II ·Ongoing·Stryker Corporation·November 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005

FDA Enforcement
Class II ·Ongoing·Stryker Corporation·November 15, 2023

Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

FDA Enforcement
Class II ·Ongoing·Genicon, Inc.·June 17, 2020

Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

FDA Enforcement
Class II ·Ongoing·Genicon, Inc.·June 17, 2020

Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

FDA Enforcement
Class II ·Ongoing·Genicon, Inc.·June 17, 2020

Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

FDA Enforcement
Class II ·Ongoing·Genicon, Inc.·June 17, 2020

Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·December 17, 2025

Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010

FDA Enforcement
Class II ·Ongoing·Healthmark Industries Co., Inc.·June 11, 2025

Brilliance iCT Computed Tomography X-ray system, Model 728306

FDA Enforcement
Class III ·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016

Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V

FDA Enforcement
Class II ·Terminated·Sonesta Medical Ab·May 10, 2017

iCT, Model # 728306, computed tomography x-ray system

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019

Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016

Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·April 19, 2023

EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·July 10, 2024

Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

Brilliance iCT - Model 728306 Computed Tomography X-ray systems

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·April 19, 2023