49 results
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55ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZAP SURGICAL SYSTEMS INC.
FDA registration
ZAP SURGICAL SYSTEMS INC.·2 products·🇺🇸 United States
DoseGuard
FDA UDI
ZAP SURGICAL SYSTEMS, INC.·00860183001580·The ZAP-X includes an integrated transit dosime...
Zap-X Treatment Planning Software
FDA UDI
ZAP SURGICAL SYSTEMS, INC.·00860183001528·The Zap-X Treatment Planning Software is design...
ZAP-Axon Treatment Planning System
FDA UDI
ZAP SURGICAL SYSTEMS, INC.·00860183001573·The dedicated software application used to crea...
PinZ Patient Immobilizer
FDA UDI
ZAP SURGICAL SYSTEMS, INC.·00860014658303·An optional accessory designed for rigid head i...
Kit, Container, Head Immobilizer
FDA UDI
ZAP SURGICAL SYSTEMS, INC.·00860183001542·An optional accessory designed for rigid head i...
Zap-X Treatment Delivery Software
FDA UDI
ZAP SURGICAL SYSTEMS, INC.·00860183001511·The Zap-X Treatment Delivery Software is design...
Kit, Container, Fixation Pins, Immobilizer
FDA UDI
ZAP SURGICAL SYSTEMS, INC.·00860183001597·An optional accessory designed for rigid head i...
Zap-X Radiosurgery System
FDA UDI
ZAP SURGICAL SYSTEMS, INC.·00860183001504·The self-shielded ZAP-X® Radiosurgery System is...
Zap-X MV Imager
FDA UDI
ZAP SURGICAL SYSTEMS, INC.·00860183001535·The Zap-X MV Imager is designed for use with th...
ZAP-X RADIOSURGERY SYSTEM
FDA Adverse Event
Malfunction
·ZAP SURGICAL SYSTEMS INC.·Product code IYE·June 16, 2022
ZAP-X RADIOSURGICAL SYSTEM
FDA Adverse Event
Malfunction
·ZAP SURGICAL SYSTEMS INC.·Product code IYE·July 20, 2025
ZAP-X Radiosurgery System, Model: 300150
FDA Recall
Open, Classified
·Zap Surgical Systems·Product code IYE·July 25, 2025
ZAP-X Radiosurgery System
FDA Recall
Open, Classified
·Zap Surgical Systems·Product code IYE·July 5, 2022
ZAP-X Radiosurgery System, Model: 300150
FDA Enforcement
Class II
·Ongoing·Zap Surgical Systems·October 8, 2025
ZAP-X Radiosurgery System
FDA Enforcement
Class II
·Ongoing·Zap Surgical Systems·September 21, 2022
EON MINI IPG, 16-CHANNEL RECHARGEABLE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2016
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013
PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·October 26, 2021
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·October 26, 2021