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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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IMPLANT ASSEMBLY, LEFT (IMPLANT ONLY)
Ototronix, LLC
M210L
In Commercial Distribution

  • M737M210L1 ()


  • Partially-implantable middle ear implant system
The Shockwave Medical Lithoplasty® Connector Cable is a remote actuator which connects the Lithoplasty® Generator to the Lithoplasty® Catheter and is used to activate lithotripsy energy within the balloon.
Shockwave Medical, Inc.
M732LCC825D1
Not in Commercial Distribution

  • M732LCC825D1 ()
M732LCC825D1

  • Ultrasound thrombolysis system catheter, peripheral
  • Ultrasound thrombolysis system control unit
The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries.
Shockwave Medical, Inc.
825D
In Commercial Distribution

  • M732IVLGCCD0 ()
IVLGCCD

  • Ultrasound thrombolysis system control unit
The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries.
Shockwave Medical, Inc.
825DP
In Commercial Distribution

  • M732IVLGCC0 ()
IVLGCC

  • Ultrasound thrombolysis system control unit
The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remote actuator which connects the IVL Generator to the IVL Catheter and is used to activate lithotripsy energy within the IVL balloon catheter.
Shockwave Medical, Inc.
825DP
Not in Commercial Distribution

  • M732IVLCC0 ()
IVLCC

  • Ultrasound thrombolysis system catheter, peripheral
  • Ultrasound thrombolysis system control unit
Semi-Automatic External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 450P
In Commercial Distribution

  • M727SAM450P ()


  • Non-rechargeable public semi-automated external defibrillator
13C-Spirulina Gastric Emptying Breath Test (GEBT)
ADVANCED BREATH DIAGNOSTICS, LLC
K021
In Commercial Distribution

  • M763K0211 ()


  • Carbon isotope breath test kit IVD
TriLURON (sodium hyaluronate) 1 prefilled syringe - 2 mL, 20mg per 2 mL - Professional Sample - Not for Sale
FIDIA FARMACEUTICI SPA
M71389122087901SAM1A
Not in Commercial Distribution

  • M71389122087901SAM1 ()
FID10000317

  • Synovial fluid supplementation medium
TriLURON (sodium hyaluronate) 1 prefilled syringe - 2 mL, 20mg per 2 mL
FIDIA FARMACEUTICI SPA
M71389122087901A13
Not in Commercial Distribution

  • M71389122087901A1 ()
89122-0879-01

  • Synovial fluid supplementation medium
Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles.
FIDIA FARMACEUTICI SPA
89122-0724-20
In Commercial Distribution

  • M713891220724200 ()
89122-0724-20

  • Synovial fluid supplementation medium
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