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Directed audio solution employing a fundamentally new way to deliver sound. Device is intended to improve sound clarity and speech intelligibility for individuals with hearing loss. The device is programmable and customizable by a hearing professional to a listener's hearing profile and preferences and other operating parameters are adjustable by the user.
The device consists of an amplifier and specialized speakers connectable to an audio source (e.g., television, CD player); the speakers emit an ultrasonic beam with sound waves reproduced within the beam directed at the user. It is intended to be used with or without a hearing aid(s).
An internal tinnitus software module may be activated and fitted by a hearing care professional for patient home use in the temporary relief of tinnitus symptoms. Upon module activation the device generates and delivers personalized sound output to tinnitus patients with or without hearing loss and with or without hearing aids.
TURTLE BEACH CORPORATION
HyperSound Clear 500P
Not in Commercial Distribution
- 00869138000203 ()
HPS-0500-04
- Directed listening device
ANA Screen with MDSS Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
Not in Commercial Distribution
- 00847865002448 ()
- 1 Each
6651170C
- Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex
ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2
BIO-RAD LABORATORIES, INC.
SW4.1_V2
In Commercial Distribution
- 00847865012331 ()
- 1 Each
6651170D
- Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex
Task Force® Monitor software incl. customer CD (multilingual)
CNSystems Medizintechnik GmbH
V2.3
In Commercial Distribution
- 09120073931931 ()
FHCS3043
- General-purpose multi-parameter bedside monitor
BioPlex 2200 HIV Ag-Ab Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution
- 03610520563939 ()
- 1 Each
12001442
- Laboratory instrument/analyser application software IVD
BioPlex 2200 Lyme Total Assay Protocol File CD SW4.3_v1.0
BIO-RAD LABORATORIES, INC.
4.3_v1.0
In Commercial Distribution
- 03610520506462 ()
- 1 Each
12000883
- Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
25-OH Vitamin D Assay Protocol File CD, SW4.2_v3, US
BIO-RAD LABORATORIES, INC.
SW4.2 V3
In Commercial Distribution
- 03610520506349 ()
- 1 Each
6653775A
- Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
BioPlex 2200 ToRC IgM Assay Protocol File CD SW4.3_v1
BIO-RAD LABORATORIES, INC.
4.3_v1
In Commercial Distribution
- 03610520150269 ()
- 1 Each
12000671
- Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
- Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
- Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
Soprano® 10 Livento® press Shade C-D Kit
Cendres+Métaux SA
08055074
In Commercial Distribution
- 07640173094791 ()
08055074
- Dental appliance fabrication material, ceramic
EZ™ Software CD & Data Cable for ECG Monitor
VASOMEDICAL, INC.
Model EZ
In Commercial Distribution
- 00817980021396 ()
A13-0040
- Electrocardiographic long-term ambulatory recording analyser application software
No Description
Zimmer, Inc.
82-0156-858-63
In Commercial Distribution
- 00889024488625 ()
- CR Provisional, 3-9/ C-D, Right
- Height: 9 Millimeter
82-0156-858-63
- Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-858-62
In Commercial Distribution
- 00889024488618 ()
- Height: 8 Millimeter
- CR Provisional, 3-9/ C-D, Right
82-0156-858-62
- Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-858-61
In Commercial Distribution
- 00889024488601 ()
- CR Provisional, 3-9/ C-D, Left
- Height: 9 Millimeter
82-0156-858-61
- Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-858-60
In Commercial Distribution
- 00889024488595 ()
- Height: 8 Millimeter
- CR Provisional, 3-9/ C-D, Left
82-0156-858-60
- Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
42-5562-034-15
In Commercial Distribution
- 00889024561755 ()
- Size CD, 15 mm, Thickness
42-5562-034-15
- Knee arthroplasty wedge
No Description
Zimmer, Inc.
42-5562-033-15
In Commercial Distribution
- 00889024561748 ()
- Size CD, 15 mm, Thickness
42-5562-033-15
- Knee arthroplasty wedge
No Description
Zimmer, Inc.
42-5562-032-15
In Commercial Distribution
- 00889024561731 ()
- Size CD, 15 mm, Thickness
42-5562-032-15
- Knee arthroplasty wedge
No Description
Zimmer, Inc.
42-5562-031-15
In Commercial Distribution
- 00889024561724 ()
- Size CD, 15 mm, Thickness
42-5562-031-15
- Knee arthroplasty wedge
No Description
Zimmer, Inc.
42-5562-034-10
In Commercial Distribution
- 00889024561557 ()
- Size CD, 10 mm, Thickness
42-5562-034-10
- Knee arthroplasty wedge
No Description
Zimmer, Inc.
42-5562-033-10
In Commercial Distribution
- 00889024561540 ()
- Size CD, 10 mm, Thickness
42-5562-033-10
- Knee arthroplasty wedge