Fidia Farmaceutici S P A

FDA Filings

This page includes the latest FDA filings for Fidia Farmaceutici S P A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9610200
FEI Number3002806986
NameVivian Kelly
Owner & OperatorFIDIA FARMACEUTICI SPA
Contact AddressVIA PONTE DELLA FABBRICA 3/A
ABANO TERME IT-PD Padova 35031 IT
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address100 Campus Drive, Suite 105
Florham Park, NJ 07932 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
FIDIA FARMACEUTICI SPA
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 pack 89122-0496-012022-10-04
FIDIA FARMACEUTICI SPA
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe FID1857042022-09-16
FIDIA FARMACEUTICI SPA
RICHPLAT ORTHO PRP SYSTEM FPRP202021-04-02
FIDIA FARMACEUTICI SPA
HYALO GYN Vaginal Hydrating Gel, 10g Tube - Made without Parabens Sample 3797042021-04-02
FIDIA FARMACEUTICI SPA
HYALO GYN Vaginal Hydrating Gel, 30g Tube - Made without Parabens 1797042021-04-02
FIDIA FARMACEUTICI SPA
HYALO GYN Vaginal Moisturizing Suppositories Sample 100004052021-04-02
FIDIA FARMACEUTICI SPA
HYALO GYN Vaginal Moisturizing Suppositories 100004042021-04-02
FIDIA FARMACEUTICI SPA
Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL 89122-0724-202021-03-25
FIDIA FARMACEUTICI SPA
Hyalgan® Sodium Hyaluronate 2mL Vial 89122-0724-122021-03-25
Fidia Farmaceutici S.p.A
HyaloGYN Vaginal Moisturizing Suppositories2020-01-09
FIDIA FARMACEUTICI SPA
TriLURON FID100003172019-11-12
FIDIA FARMACEUTICI SPA
TriLURON 89122-0879-012019-11-12
Fidia Farmaceutici S.p.A.
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2019-11-05
Vivian Kelly [FIDIA FARMACEUTICI SPA]
Triluron2019-09-20
FIDIA FARMACEUTICI SPA
HYALGAN2016-08-26
Vivian Kelly [FIDIA FARMACEUTICI SPA]
Hyalo GYN2015-09-24
Vivian Kelly [FIDIA FARMACEUTICI SPA]
Hymovis2015-09-16
FIDIA FARMACEUTICI SPA
HyaloGYN Vaginal Hydrating Gel2015-09-01
FIDIA FARMACEUTICI SPA
HYALGAN2013-09-26
FIDIA FARMACEUTICI SPA
2011-05-01
Vivian Kelly [FIDIA FARMACEUTICI SPA]
Hyalogyn2011-01-21
FIDIA FARMACEUTICI SPA
HYALO GYN2010-05-07
FIDIA FARMACEUTICI SPA
HYALGAN2010-03-28
FIDIA FARMACEUTICI SPA
HYALGAN2008-05-23
FIDIA FARMACEUTICI SPA
HYALGAN2008-05-01
FIDIA FARMACEUTICI SPA
HYALGAN2008-01-08
Vivian Kelly [FIDIA FARMACEUTICI SPA]
Hyalgan2007-12-17
Vivian Kelly [FIDIA FARMACEUTICI SPA]
Bionect Hydrogel Foam2007-12-17
Vivian Kelly [FIDIA FARMACEUTICI SPA]
Bionect Clear Hydrogel2007-12-17
Vivian Kelly [FIDIA FARMACEUTICI SPA]
Bionect Hydrogel Spray2007-12-17
Vivian Kelly [FIDIA FARMACEUTICI SPA]
Bionect Hydrogel Foam2007-12-17
Vivian Kelly [FIDIA FARMACEUTICI SPA]
Bionect Cream2007-12-17
FIDIA FARMACEUTICI SPA
HYALGAN2005-07-19
FIDIA FARMACEUTICI SPA
HYALGAN2000-08-30
FIDIA FARMACEUTICI SPA
HYALGAN(R)1999-12-18
FIDIA FARMACEUTICI SPA
HYALGAN(R)1999-12-18
FIDIA FARMACEUTICI SPA
HYALGAN(R)1997-07-08
FIDIA FARMACEUTICI SPA
HYALGAN(R)1997-05-28

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020082752695Livorno,Italy -> Savannah, GeorgiaONTO 21 EURO-PALLETS ORTHOPEDIC PRODUCT, HY MOVIS BOX OF 2 SYR. 24MG + HYMOVIS BOX OF 2 S YR. 24MG - SAMPLE HTSUS / HS CODE: 9021 1010 INVOICE NO. 2100000248 FINAL DESTINATION: CAR DINAL SPS 501 MASON ROAD, SUITE 200, LA VERGN E, TN 37086 USA CUSTOM'S BROKER: DHL GLOBAL F ORWARDING, 2500-A SULLIVAN ROAD,COLLEGE PARK,185 CTN
2020072123617Genova,Italy -> Miami, FloridaONTO 16 EURO-PALLETS MEDICAL DEVICE, HYALOGYN 30G TUBE + HYALO-GYN TUBO G 10 SM HS CODE: 3 004 9000 HTSUS: 3004901000 INVOICE NO. 210000 0180 - 2100000181 FINAL DESTINATION: PRONOVA CORP 5000 SW 75TH AVE, SUITE 113, MIAMI FL 33 155 USA CUSTOM'S BROKER: DHL GLOBAL FORWARDIN G, 2500-A SULLIVAN ROAD,COLLEGE PARK, ATLANTA563 CTN
2020042815365Genova,Italy -> Savannah, GeorgiaONTO 23 EURO-PALLETS MEDICAL DEVICE, HYALGAN 20 MG/2 ML PRE-FILLED SYRINGE HS CODE: 3004 9 000 HTSUS: 3004901000 INVOICE NO. 2100000092 FINAL DESTINATION: CARDINAL SPS 501 MASON ROA D, SUITE 200, LA VERGNE, TN 37086 USA559 CTN
2020032310769Genova,Italy -> Savannah, GeorgiaONTO 20 EURO - PALLETS MEDICAL DEVICE, TRILUR ON SYRINGE 2ML + SAMPLE HS CODE: 3004 9000 HT SUS: 3004901000 INVOICE NO. 2100000041-42 FIN AL DESTINATION: CARDINAL SPS 501 MASON ROAD, SUITE 200, LA VERGNE, TN 37086 USA CUSTOM'S BROKER: DHL GLOBAL FORWARDING, #2500-A SULLIV AN ROAD, ATLANTA GA 30337,USA SHARON.WOODS@DH225 CTN
2020021733790Genova,Italy -> Savannah, GeorgiaONTO 23 EURO-PALLETS MEDICAL DEVICE, HYALGAN 20MG/2ML PRE-FILLED SYRINGE HS CODE: 3004 900 0 HTSUS: 3004901000 INVOICE NO. 2100000008 FI NAL DESTINATION: FIDIA PHARMA USA INC. C/O CA RDINAL SPS LOGISTICS SERVICES, 501 MASON ROAD , SUITE 200, LA VERGNE, TN 37086 USA CUSTOM'S BROKER: DHL GLOBAL FORWARDING, 2500-A SULLIV562 CTN
2019120226982Genova,Italy -> Savannah, GeorgiaONTO 17 EURO-PALLETS MEDICAL DEVICE, HYALGAN 20MG/2ML PRE-FILLED SYRINGE HS CODE: 3004 901 0 HTSUS: 3004901000 INVOICE NO. 2100000355 FI NAL DESTINATION: FIDIA PHARMA USA INC. C/O CA RDINAL HEALTH THIRD PARTY LOGISTICS SERVICES, 501 MASON ROAD, SUITE 200, LA VERGNE, TN 370 86 USA CUSTOM'S BROKER: DHL GLOBAL FORWARDING338 CTN
2019120226983Genova,Italy -> Savannah, GeorgiaONTO 23 EURO-PALLETS MEDICAL DEVICE, HYALGAN 20MG/2ML PRE-FILLED SYRINGE HS CODE: 3004 90 10 HTSUS: 3004901000 INVOICE NO. 2100000356 F INAL DESTINATION: FIDIA PHARMA USA INC. C/O C ARDINAL HEALTH THIRD PARTY LOGISTICS SERVICES , 501 MASON ROAD, SUITE 200, LA VERGNE, TN 37 086 USA CUSTOM'S BROKER: DHL GLOBAL FORWARDIN557 CTN
2019082643240La Spezia,Italy -> Savannah, GeorgiaHYALGAN 10MG/ML244 BOX

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