43 results
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15ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and coagulation
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 21, 2017
Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.
FDA Enforcement
Class II
·Terminated·Capintec Inc·September 12, 2012
Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS
FDA Enforcement
Class II
·Terminated·Lockheed Martin Gyrocam Systems, Inc.·February 20, 2013
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·January 30, 2019
DR 800. Digital Radiography X-ray System.
FDA Enforcement
Class II
·Ongoing·Agfa N.V.·September 4, 2024
MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display
FDA Enforcement
Class II
·Completed·Barco N.V.·July 17, 2024
Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
FDA Enforcement
Class II
·Terminated·Materialise N.V.·March 25, 2015
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
FDA Enforcement
Class II
·Terminated·Materialise N.V.·November 4, 2015
DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.
FDA Enforcement
Class II
·Terminated·Agfa N.V.·October 3, 2018
Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC-1119).
FDA Enforcement
Class II
·Terminated·Barco N.V.·December 12, 2018
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications.
FDA Enforcement
Class II
·Terminated·Agfa N.V.·August 7, 2019
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications
FDA Enforcement
Class II
·Terminated·Agfa N.V.·June 10, 2020
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
FDA Enforcement
Class II
·Terminated·Materialise N.V.·March 25, 2020
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
FDA Enforcement
Class II
·Terminated·Materialise N.V.·March 25, 2020
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
FDA Enforcement
Class II
·Terminated·Agfa N.V.·March 25, 2020
Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.
FDA Enforcement
Class II
·Terminated·Materialise N.V.·September 2, 2020
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
FDA Enforcement
Class II
·Completed·Materialise N.V.·August 9, 2023
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
FDA Enforcement
Class II
·Terminated·Barco N.V.·March 10, 2021
MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01
FDA Enforcement
Class II
·Completed·Materialise N.V.·July 26, 2023
Barco MDSC-8527 NXF, Part Number K9352421
FDA Enforcement
Class II
·Ongoing·Barco N.V.·February 14, 2024