11 results
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50ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
FDA Recall
Terminated
·Abbott Medical Optics, Inc.·Product code HQC·May 23, 2013
Medtronic 3778 Lead Kit, 1x8 Compact Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604.
FDA Recall
Terminated
·Medtronic Neurological·Product code LGW·August 2, 2006
Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms.
FDA Recall
Terminated
·Spacelabs Healthcare Inc·Product code MHX·May 8, 2015
Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604.
FDA Recall
Terminated
·Medtronic Neurological·Product code LGW·August 2, 2006
Fabius Tiro Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 Compact anesthesia system that offers the full spectrum of anesthesia ventilation to military anesthesiologists/ CRNAs in the field of operations. Can be used in a variety of mobile and stationary military applications where general anesthesia is required.
FDA Recall
Terminated
·Draeger Medical Systems, Inc.·Product code BSZ·August 26, 2010
LUMINOS Lotus Max (VF11)
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·November 23, 2022
Luminos dRF Max (VE10, VF10, VF11)
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·November 23, 2022
Luminos Agile Max (VE10, VF10, VF11)
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·November 23, 2022
OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic procedures. These tables are suitable to use for diagnostic x-ray imaging and imaging during therapeutic procedures such as spinal injections, vertebroplasty procedures and other pain management procedures. The CFLU Table is designed for Lithotripsy and Urology procedures. It is intended to be operated by a healthcare professional in a medical environment. No special training is required but a review of the Safety Instructions is important for the safety of the operator and patient.
FDA Recall
Terminated
·Oakworks Inc·Product code IXR·May 2, 2019
Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric fractures
FDA Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code JEC·November 21, 2019
Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate The Officemate, FSIII and FSIIIc are compact mobile fluoroscopic C-arm systems specifically designed for x-ray imaging of extremities. The systems are used by trained medical personnel, but at times are used for non medical applications. The functionality of the units is identical for the OfficeMate, FSIII and FSIIIc. Also the construction of the different models is identical. That includes the mounting of the flex arm to the cabinet and the flex arm to the C-arm. The difference between the models resides in the monitors: " Officemate has one small monitor " FSIII has two larger monitors " FSIIIc is an international version of the FSIII (power kit)
FDA Recall
Terminated
·Hologic, Inc.·Product code JAA·July 21, 2011