fidiapharma.usHYALGAN
FIDIA FARMACEUTICI SPA
FIDIA FARMACEUTICI SPA
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9610200 | 3002806986 | FIDIA FARMACEUTICI SPA | 1 | N | 2026-01-01 | VIA PONTE DELLA FABBRICA 3/A ABANO TERME Padova IT 35031 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| M7131797040 | Hyalo GYN Vaginal Hydrating Gel - Made without Parabens - HYALO GYN® Vaginal Hydrating Gel, 30g Tube - Made without Parabens is a personal lubricant for vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with polyisoprene condoms. | 973-577-6202 | regulatory@fidiapharma.us |
| M7133797040 | Hyalo GYN Vaginal Hydrating Gel - Made without Parabens Sample - HYALO GYN® Vaginal Hydrating Gel, 10g Tube - Made without Parabens Sample is a personal lubricant for vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with polyisoprene condoms. | 973-577-6202 | regulatory@fidiapharma.us |
| M713891220750010 | HYMOVIS® ONE 32mg/4ml syringe - HYMOVIS® ONE Viscoelastic Hyaluronan is an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® ONE is derived from bacterial fermentation. HYMOVIS® ONE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in single injection regimen. The product is packaged in a one syringe pack. | 9735776202 | compliance@fidiapharma.us |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 16568 | 1460383145 | P950027 | HYALGAN(R) | MOZ | 1997-05-28 |
| 16568 | 1159509043 | P180040 | TRILURON | MOZ | 2019-03-26 |
| 16568 | 2061786088 | P150010 | HYMOVIS | MOZ | 2015-08-28 |
| 16568 | 1219753642 | K984267 | MODIFICATION OF BIONECT HYDROGEL FOAM | MGQ | 1999-02-10 |
| 16568 | 1737879289 | K973725 | BIONECT CLEAR HYDROGEL | MGQ | 1998-09-22 |
| 16568 | 1233449017 | K973724 | BIONECT HYDROGEL SPRAY | MGQ | 1998-09-22 |
| 16568 | 1439360072 | K973722 | BIONECT HYDROGEL FOAM | MGQ | 1998-09-22 |
| 16568 | 1454915014 | K963004 | BIONECT CREAM | MGQ | 1997-02-12 |
| 16568 | 1545377465 | K191052 | HyaloGYN Vaginal Moisturizing Suppositories | NUC | 2020-01-09 |
| 16568 | 1240308206 | K150883 | HyaloGYN Vaginal Hydrating Gel | NUC | 2015-09-01 |
| 16568 | 1433811887 | K094039 | HYALO GYN | NUC | 2010-05-07 |
| 16568 | 1468367281 | BK180296 |
Product Codes Associated With Registrations#
PMA#
HYALGAN
FIDIA FARMACEUTICI SPA
HYALGAN
FIDIA FARMACEUTICI SPA
HYALGAN
FIDIA FARMACEUTICI SPA
HYALGAN
FIDIA FARMACEUTICI SPA
HYALGAN
FIDIA FARMACEUTICI SPA
HYALGAN
FIDIA FARMACEUTICI SPA
HYALGAN
FIDIA FARMACEUTICI SPA
HYALGAN(R)
FIDIA FARMACEUTICI SPA
HYALGAN(R)
FIDIA FARMACEUTICI SPA
HYALGAN(R)
FIDIA FARMACEUTICI SPA
HYALGAN(R)
FIDIA FARMACEUTICI SPA
PMN#
HyaloGYN Vaginal Hydrating Gel
FIDIA FARMACEUTICI SPA
HYALO GYN
FIDIA FARMACEUTICI SPA
GUDID#
HYALO GYN Vaginal Hydrating Gel, 30g Tube - HYALO GYN® is a personal lubricant, for penile and/or vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with condoms: lubricated/nonlubricated latex, lubricated polyurethane, lubricated natural skin.
2016-11-01
Hyalo GYN Vaginal Hydrating Gel - Made without Parabens - HYALO GYN® Vaginal Hydrating Gel, 30g Tube - Made without Parabens is a personal lubricant for vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with polyisoprene condoms.
2021-03-25
Hyalo GYN Vaginal Hydrating Gel - Made without Parabens Sample - HYALO GYN® Vaginal Hydrating Gel, 10g Tube - Made without Parabens Sample is a personal lubricant for vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with polyisoprene condoms.
2021-03-25
HYMOVIS® ONE 32mg/4ml syringe - HYMOVIS® ONE Viscoelastic Hyaluronan is an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® ONE is derived from bacterial fermentation. HYMOVIS® ONE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in single injection regimen. The product is packaged in a one syringe pack.
2025-11-07
HYMOVIS® ONE Professional Sample, 32mg/4ml syringe - HYMOVIS® ONE Viscoelastic Hyaluronan is an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® ONE is derived from bacterial fermentation. HYMOVIS® ONE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in single injection regimen. The product is packaged in a one syringe pack.
2025-11-07
RICHPLAT ORTHO 40 PRP SYSTEM - The RICHPLAT ORTHO® 40 Platelet Rich Plasma System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
2025-10-31
RICHPLAT ORTHO PRP SYSTEM - The RICHPLAT ORTHO® 20 Platelet Rich Plasma System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
2021-03-25
COL-FID4 Care Collagen Wound Dressing - COL-FID 4 CARE Collagen is a native 100% Bovine Type 1 collagen, which when applied to a wound surface, absorbs wound exudate, and maintains a moist wound environment to aid in the management of wound healing. COL-FID 4 Care Collagen Dressing may be used in the management of partial and full thickness wounds,pressure (stage I-IV) and venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis and diabetic ulcers, cuts, and abrasions. Each carton contains 5 dressings and each case contains 10 cartons.
2025-11-24
Hyalgan® Sodium Hyaluronate 2mL Vial - Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial 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. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.
2015-07-31
TriLURON - TriLURON (sodium hyaluronate) 1 prefilled syringe - 2 mL, 20mg per 2 mL
2019-11-04
Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL - 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. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.
2015-07-31
TRILURON - TRILURON (sodium hyaluronate) 1 prefilled syringe - 2 mL, 20mg per 2 mL
2024-05-07
Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL - 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.
2023-10-16
Hyalgan® Sodium Hyaluronate 2mL Vial - Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial 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. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.
2023-09-13
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe - HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals.
2016-03-21
Hyalo4 Care Clear Hydrogel, 30g - Clear hydrogel wound dressing, 30g, Professional Sample
2023-06-14
Hyalo4 Care Clear Hydrogel, 100g - Clear hydrogel wound dressing, 100g Tube
2023-06-14
Hyalo4 Care Hydrogel, 25g - Hydrogel wound dressing, 25g, Professional Sample
2023-06-14
Hyalo4 Care Hydrogel, 100g - Hydrogel wound dressing, 100g Tube
2023-06-14
HYALO GYN Vaginal Moisturizing Suppositories Sample - HyaloGYN Vaginal Moisturizing Suppositories are personal lubricants, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The suppositories are made without parabens. The sample box contains 3 suppositories
2021-03-25
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 pack - HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals. The product is packaged in a one syringe pack.
2022-09-26
vH Essentials Moisturizing Vaginal Suppositories - vH Essentials Moisturizing Vaginal Suppositories are a non-hormonal moisturizer delivered in an easy-to-use suppository format. vH Essentials Moisturizing Vaginal Suppositories, intended for the temporary relief of vaginal dryness symptoms, moisturize and lubricate the vaginal epithelium to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is not compatible with natural rubber latex, polyurethane and polyisoprene condoms.
2022-09-15
CVS Health Moisturizing Vaginal Suppositories - CVS Health™ Moisturizing Vaginal Suppositories are a non-hormonal moisturizer delivered in an easy-to-use suppository format. CVS Health™ Moisturizing Vaginal Suppositories, intended for the temporary relief of vaginal dryness symptoms, moisturize and lubricate the vaginal epithelium to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is not compatible with natural rubber latex, polyurethane and polyisoprene condoms.
2022-09-15
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe - HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals.
2017-02-12
HYALO GYN Vaginal Moisturizing Suppositories - HyaloGYN Vaginal Moisturizing Suppositories are personal lubricants, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The suppositories are made without parabens. Packaged as a box of 10 suppositories.
2021-03-25
TriLURON - TriLURON (sodium hyaluronate) 1 prefilled syringe - 2 mL, 20mg per 2 mL - Professional Sample - Not for Sale
2019-11-04
HYALO GYN Vaginal Hydrating Gel, 10g Tube - HYALO GYN® is a personal lubricant, for penile and/or vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with condoms: lubricated/nonlubricated latex, lubricated polyurethane, lubricated natural skin.
2016-11-01
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe - HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).
2015-11-06
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe - HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).
2017-02-12