29 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Recall
Terminated
·Nidek Inc·Product code GEX·March 25, 2015
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Recall
Terminated
·Nidek Inc·Product code GEX·March 25, 2015
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Recall
Terminated
·Nidek Inc·Product code GEX·May 16, 2014
Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Enforcement
Class II
·Terminated·Nidek Inc·July 22, 2015
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Enforcement
Class II
·Terminated·Nidek Inc·July 22, 2015
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Enforcement
Class II
·Terminated·Nidek Inc·August 20, 2014
MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).
FDA Recall
Terminated
·Medical Information Technology, Inc.·Product code JQP·February 21, 2014
Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
FDA Recall
Terminated
·Vital Concepts, Inc.·Product code GCY·July 11, 2003
GE Healthcare Definium 5000 / 5220493 X-Ray System
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAC·September 26, 2012
Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
FDA Recall
Terminated
·Beekley Corporation·Product code JAC·July 9, 2012
Beekley Medical 0-SPOT Mammography Skin Markers REF 652
FDA Recall
Terminated
·Beekley Corporation·Product code JAC·May 8, 2017
Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
FDA Recall
Terminated
·Ad-Tech Medical Instrument Corporation·Product code GYC·December 18, 2012
Curix Ultra UV-L Plus, Medical Screen Film, X-ray Film, 14x17, 100 Sheet Box
FDA Recall
Terminated
·AGFA Corp.·Product code JAC·February 16, 2006
Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800, 688-624200, 688-624300, 842-687900, 672-610800F. Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe.
FDA Recall
Terminated
·CareFusion 209 Inc.·Product code GYC·October 5, 2011
Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain
FDA Recall
Terminated
·Beekley Corporation·Product code JAC·July 9, 2012
S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.
FDA Recall
Terminated
·Beekley Corporation·Product code JAC·June 13, 2018
Radiomat SG, 11x14, Medical Screen Film, X-ray Film, 100 Sheet Box and 14x17, 100 Sheet Box
FDA Recall
Terminated
·AGFA Corp.·Product code JAC·February 16, 2006
Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
FDA Recall
Terminated
·Integra Burlington MA, Inc.·Product code GYC·March 18, 2013
O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
FDA Recall
Terminated
·Beekley Corporation·Product code JAC·June 13, 2018
Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
FDA Recall
Terminated
·Ad-Tech Medical Instrument Corporation·Product code GYC·June 18, 2019