Device, Surgical, Cryogenic
FDA product code GXH · 20 cleared devices
Class 2
Neurology
- Regulation
- 21 CFR 882.4250
- Review panel
- NE
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1978-08-15 – 2025-04-10
GXH
2025-04-10
GXH
2024-12-26
iovera° System
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GXH
2024-10-29
AtriCure cryoICE BOX (ACM)
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GXH
2023-10-26
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
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GXH
2022-05-20
iovera System
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GXH
2021-09-10
Iovera System
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GXH
2020-12-23
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
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GXH
2018-11-09
AtriCure cryoICE cryoSPHERE cryoablation probe
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GXH
2018-02-28
iovera system
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GXH
2018-02-15
AtriCure cryoICE cryo-ablation probe (CRYO2)
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GXH
2017-03-24
iovera system
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GXH
2013-01-10
CRYO-TOUCH IV
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GXH
2012-06-22
CRYO-TOUCH III
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GXH
2010-09-17
CRYO-TOUCH II
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GXH
2010-06-25
MYOSCIENCE CRYO-TOUCH
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GXH
2005-03-24
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
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GXH
2003-07-10
CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE
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GXH
1986-04-30
PAINBLOCKER WA5000
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GXH
1983-08-12
CRYOMEDICS NEUROSTAT
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GXH
1978-08-15
NEUROSTAT, LLOYD
View details →No matching devices.
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