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Intraoperative System Analyzer (ISA), Software and Computer
Envoy Medical Corporation
3001
In Commercial Distribution
- 00812282020160 ()
903001-003
- Fully-implantable middle ear implant system
Clinician Programmer Software for H200 Wireless System
Bioness Medical, Inc.
H2W-SW01
- Hand orthosis
Clinician Programmer Software for L300 Go System
Bioness Medical, Inc.
LG4-SW01
- Gait-enhancement electrical stimulation system, external
Clinician Programmer Software for L300 Go system
BIONESS INC.
LG4-SW01
In Commercial Distribution
- 00815962020061 ()
- Gait-enhancement electrical stimulation system, external
Lumax™ TS Pro Advanced • Software Kit
Coopersurgical, Inc.
23486
In Commercial Distribution
- 60888937013391 ()
- Urodynamic measurement system
AIDA compact II Software Upgrade (v.2.4
Karl Storz GmbH & Co. KG
20040502-U02
In Commercial Distribution
- 04048551060049 ()
- Operating room audiovisual data/device management system application software
AIDA compact II Software HD (v.2.3)
Karl Storz GmbH & Co. KG
20040402-15
In Commercial Distribution
- 04048551032558 ()
- Operating room audiovisual data/device management system application software
Speech Articulation: Animation of Muscle Vectors, Software
PENTAX OF AMERICA, INC.
5154
Not in Commercial Distribution
- 04961333229857 ()
- Electroglottograph
Software Kit FACSDiva 9.4 RUO w/Dongle
BECTON, DICKINSON AND COMPANY
664286
Not in Commercial Distribution
- 00382906642868 ()
664286
- Laboratory instrument/analyser application software IVD
Natus Elite v2 Software - Synergy & Viking Combo
NATUS NEUROLOGY INCORPORATED
828-080300
In Commercial Distribution
- 00382830062220 ()
- Electromyograph
NeuroWorks TrexHD Monitoring Software Installation Media (US)
XLTEK
021764
In Commercial Distribution
- 00382830043380 ()
- Electroencephalograph
EMG Software Upgrade with New System Order
NATUS NEUROLOGY INCORPORATED
017806
In Commercial Distribution
- 00382830061933 ()
- Electromyograph
BD FACSCount System Users Guide and Software
Becton, Dickinson And Company
344619
In Commercial Distribution
- 00382903446193 ()
344619
- Laboratory instrument/analyser application software IVD
Natus Elite - Synergy & Viking Combo Master Software
NATUS NEUROLOGY INCORPORATED
828-069500
In Commercial Distribution
- 00382830035019 ()
- Electromyograph
Aurora Xi Plasmapheresis System Software Version 1.2
Fresenius Kabi AG
1.2
In Commercial Distribution
- 04086000101967 ()
- Apheresis system
Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70845
70845
- Electrical-only medical device connection cable, reusable
Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70845
Not in Commercial Distribution
- 30093815000830 ()
- 00093815000839 ()
- 57599-0845-1 ()
70845
- Electrical-only medical device connection cable, reusable
PillCam™ Software v9.0 for WS, USA
Given Imaging, Inc.
FGS-0637
In Commercial Distribution
- 07290110360191 ()
- Video capsule endoscopy system application software
Site~Rite 9 Ultrasound Software v.1.2.0
Bard Access Systems, Inc.
SR9v1.2.0
In Commercial Distribution
- 00801741231186 ()
SR9v1.2.0
- Central venous catheter navigation system, electrocardiographic/magnetic
- General-purpose ultrasound imaging system
Site Rite 8 Ultrasound System Application Software
Bard Access Systems, Inc.
SR8v2.4.0
In Commercial Distribution
- 00801741219405 ()
SR8v2.4.0
- General-purpose ultrasound imaging system
Site~Rite 8 Ultrasound System Host Software
Bard Access Systems, Inc.
SR8 USv2.1.0
In Commercial Distribution
- 00801741161094 ()
SR8 USv2.1.0
- General-purpose ultrasound imaging system
Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.51.0
In Commercial Distribution
- 00810020441208 ()
- Apheresis system
Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.13.0
In Commercial Distribution
- 00810020440591 ()
- Apheresis system
Cytomics FC 500 MPL with MXP Software
Beckman Coulter, Inc.
UPS (MPL)
In Commercial Distribution
- 15099590572822 ()
626554
- Flow cytometry analyser IVD, semi-automated
BT12 ECG AHA WITH SPIROTRAC 6 SOFTWARE
VITALOGRAPH (IRELAND) LIMITED
4130
In Commercial Distribution
- 05099169413337 ()
- 15099169413334 ()
- Electrocardiograph, professional, multichannel
BT-12 ECG IEC with SPIROTRAC 6 SOFTWARE
VITALOGRAPH (IRELAND) LIMITED
4130
In Commercial Distribution
- 05099169413306 ()
- 15099169413303 ()
- Electrocardiograph, professional, multichannel
NAVIOS EX TETRA SOFTWARE V2.0 NEW USER
BECKMAN COULTER IRELAND INC.
TETRA SOFTWARE V2.0 NEW USER
In Commercial Distribution
- 15099590683276 ()
B91240
- Laboratory instrument/analyser application software IVD
ViroSeq HIV-1 Genotyping Software v3.0 & Algorithm Advisor
ABBOTT MOLECULAR INC.
4J94-23
In Commercial Distribution
- 00884999039278 ()
4J94-23
- Laboratory instrument/analyser application software IVD
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF001
Not in Commercial Distribution
- 00850013007042 ()
ELF001
- Audiometric/hearing device software
Software, TomoApps, Version 5.1.3
Operating Software for TomoTherapy systems (including TomoH, TomoHD, TomoHDA) and Onrad Treatment System.
ACCURAY INCORPORATED
1062424
In Commercial Distribution
- M65810624240 ()
NA
- Linear accelerator system