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The Inspire® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG) for treatment of obstructive sleep apnea.
Inspire Medical Systems, Inc.
900-014-005
In Commercial Distribution
- 10810098650301 ()
4340
- Implantable sleep apnoea treatment system, respiration-sensing
DUROLANE is a clear, viscous gel that contains highly purified sodium hyaluronate. This substance acts as a lubricant and shock absorber in the knee joint. DUROLANE is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
SAIMA GLOBAL FARMA S.L.
1082020
In Commercial Distribution
- 08437027710001 ()
- Synovial fluid supplementation medium
The Model 2502 Clinician Programmer (CP) is a non-sterile external component that consists of a commercially available laptop computer configured with customized software. The CP connects to the Mobile Charger with a custom Programmer Cable. The CP enables the clinician to enter and modify therapy parameters and therapy schedule in the Rechargeable Neuroregulator. The graphical user interface of the CP allows the clinician to monitor system performance and patient compliance. The CP also provides access to the Instructions for Use manuals.
Reshape Lifesciences Inc.
2502
Not in Commercial Distribution
- 00857334004354 ()
2502
- Vagus nerve electrical stimulation system programmer
DUROLANE is a clear, transparent, viscous gel of highly purified, stabilized, non-animal-derived sodium hyaluronate that is biosynthesized using bacterial fermentation. NASHA® technology is used to stabilize naturally entangled hyaluronic acid (HA) chains to produce a gel. The gel is suspended in phosphate-
buffered saline at a concentration of 20 mg/mL. DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen.
BIOVENTUS LLC
1082020
In Commercial Distribution
- 00816986020808 ()
- 10816986020805 ()
- 89130-2020-1 ()
1082020
- Synovial fluid supplementation medium
The Sentimag system is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.
ENDOMAGNETICS LTD
SMB02
In Commercial Distribution
- 15060391210008 ()
- Magnetic metal detector
Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline delivery conduit, syringe
and saline supply line with spiked end.
AEGEA MEDICAL INC.
DDK-16-050
In Commercial Distribution
- 00857379006030 ()
DDK-16-050
- Water vapour endometrial-ablation applicator
Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense CGM User Guide, Eversense CGM Quick Reference Guide and a wallet card.
SENSEONICS, INCORPORATED
FG-3302-01-001
Not in Commercial Distribution
- 00817491022516 ()
FG-3302-01-001
- Implantable glucose monitoring system transmitter
Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense CGM User Guide, Eversense CGM Quick Reference Guide and a wallet card.
SENSEONICS, INCORPORATED
FG-3301-01-001
Not in Commercial Distribution
- 00817491021458 ()
FG-3301-01-001
- Implantable glucose monitoring system transmitter
Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense CGM User Guide, Eversense CGM Quick Reference Guide and a wallet card.
SENSEONICS, INCORPORATED
FG-3300-01-001
Not in Commercial Distribution
- 00817491021441 ()
FG-3300-01-001
- Implantable glucose monitoring system transmitter
Buccal Sample Collection Kit for use with AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
12-0610-01
In Commercial Distribution
- 10850009370225 ()
12-0610-01
- Oral/upper respiratory tract specimen collection kit IVD, clinical