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 Number	9610200
FEI Number	3002806986
Name	Vivian Kelly
Owner & Operator	FIDIA FARMACEUTICI SPA
Contact Address	VIA PONTE DELLA FABBRICA 3/A ABANO TERME IT-PD Padova 35031 IT
US Agent	Vivian Kelly Fidia Pharma USA Inc. 973 5776202 973 5079858 vkelly@fidiapharma.us
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	100 Campus Drive, Suite 105 Florham Park, NJ 07932 US
Establishment Type	Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID M713891220724200 FIDIA FARMACEUTICI SPA	Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL 89122-0724-20	2023-10-24
GUDID M713891220724120 FIDIA FARMACEUTICI SPA	Hyalgan® Sodium Hyaluronate 2mL Vial 89122-0724-12	2023-09-21
GUDID M713494440100350 FIDIA FARMACEUTICI SPA	Hyalo4 Care Hydrogel, 100g 49444-0100-35	2023-06-22
GUDID M713494440025080 FIDIA FARMACEUTICI SPA	Hyalo4 Care Hydrogel, 25g 49444-0025-08	2023-06-22
GUDID M713494290100350 FIDIA FARMACEUTICI SPA	Hyalo4 Care Clear Hydrogel, 100g 49429-0100-35	2023-06-22
GUDID M713494290030100 FIDIA FARMACEUTICI SPA	Hyalo4 Care Clear Hydrogel, 30g 49429-0030-10	2023-06-22
GUDID M713891220496010 FIDIA FARMACEUTICI SPA	Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 pack 89122-0496-01	2022-10-04
GUDID M71389122049663SAM1 FIDIA FARMACEUTICI SPA	Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe FID185704	2022-09-16
GUDID M713FPRP200 FIDIA FARMACEUTICI SPA	RICHPLAT ORTHO PRP SYSTEM FPRP20	2021-04-02
GUDID M7133797040 FIDIA FARMACEUTICI SPA	HYALO GYN Vaginal Hydrating Gel, 10g Tube - Made without Parabens Sample 379704	2021-04-02
GUDID M7131797040 FIDIA FARMACEUTICI SPA	HYALO GYN Vaginal Hydrating Gel, 30g Tube - Made without Parabens 179704	2021-04-02
GUDID M713100004050 FIDIA FARMACEUTICI SPA	HYALO GYN Vaginal Moisturizing Suppositories Sample 10000405	2021-04-02
GUDID M713100004040 FIDIA FARMACEUTICI SPA	HYALO GYN Vaginal Moisturizing Suppositories 10000404	2021-04-02
GUDID M71389122072420A1 FIDIA FARMACEUTICI SPA	Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL 89122-0724-20	2021-03-25
GUDID M71389122072412A1 FIDIA FARMACEUTICI SPA	Hyalgan® Sodium Hyaluronate 2mL Vial 89122-0724-12	2021-03-25
PMN K191052 Fidia Farmaceutici S.p.A	HyaloGYN Vaginal Moisturizing Suppositories	2020-01-09
GUDID M71389122087901SAM1 FIDIA FARMACEUTICI SPA	TriLURON FID10000317	2019-11-12
GUDID M71389122087901A1 FIDIA FARMACEUTICI SPA	TriLURON 89122-0879-01	2019-11-12
PMN BK180296 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
PMN P180040 \| MOZ Vivian Kelly [FIDIA FARMACEUTICI SPA]	Triluron	2019-09-20
PMA P950027S015 FIDIA FARMACEUTICI SPA	HYALGAN	2016-08-26
PMN K150883 \| NUC Vivian Kelly [FIDIA FARMACEUTICI SPA]	Hyalo GYN	2015-09-24
PMN P150010 \| MOZ Vivian Kelly [FIDIA FARMACEUTICI SPA]	Hymovis	2015-09-16
PMN K150883 FIDIA FARMACEUTICI SPA	HyaloGYN Vaginal Hydrating Gel	2015-09-01
PMA P950027S014 FIDIA FARMACEUTICI SPA	HYALGAN	2013-09-26
NDC 54873-270 FIDIA FARMACEUTICI SPA		2011-05-01
PMN K094039 \| NUC Vivian Kelly [FIDIA FARMACEUTICI SPA]	Hyalogyn	2011-01-21
PMN K094039 FIDIA FARMACEUTICI SPA	HYALO GYN	2010-05-07
PMA P950027S012 FIDIA FARMACEUTICI SPA	HYALGAN	2010-03-28
PMA P950027S011 FIDIA FARMACEUTICI SPA	HYALGAN	2008-05-23
PMA P950027S009 FIDIA FARMACEUTICI SPA	HYALGAN	2008-05-01
PMA P950027S010 FIDIA FARMACEUTICI SPA	HYALGAN	2008-01-08
PMN P950027 \| MOZ Vivian Kelly [FIDIA FARMACEUTICI SPA]	Hyalgan	2007-12-17
PMN K984267 \| MGQ Vivian Kelly [FIDIA FARMACEUTICI SPA]	Bionect Hydrogel Foam	2007-12-17
PMN K973725 \| MGQ Vivian Kelly [FIDIA FARMACEUTICI SPA]	Bionect Clear Hydrogel	2007-12-17
PMN K973724 \| MGQ Vivian Kelly [FIDIA FARMACEUTICI SPA]	Bionect Hydrogel Spray	2007-12-17
PMN K973722 \| MGQ Vivian Kelly [FIDIA FARMACEUTICI SPA]	Bionect Hydrogel Foam	2007-12-17
PMN K963004 \| MGQ Vivian Kelly [FIDIA FARMACEUTICI SPA]	Bionect Cream	2007-12-17
PMA P950027S006 FIDIA FARMACEUTICI SPA	HYALGAN	2005-07-19
PMA P950027S004 FIDIA FARMACEUTICI SPA	HYALGAN	2000-08-30
PMA P950027S003 FIDIA FARMACEUTICI SPA	HYALGAN(R)	1999-12-18
PMA P950027S002 FIDIA FARMACEUTICI SPA	HYALGAN(R)	1999-12-18
PMA P950027S001 FIDIA FARMACEUTICI SPA	HYALGAN(R)	1997-07-08
PMA P950027 FIDIA FARMACEUTICI SPA	HYALGAN(R)	1997-05-28

Similar & Related FDA Registered Companies

Fidia Farmaceutici S.p.A.via Ponte Della Fabbrica 3/aabano Terme 35031 PMA NumberP180040 Supplement NumberS004 Date Received12/23/2022 Decision Date01/19/2023 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
FIDIA FARMACEUTICI SPAvia Ponte Della Fabbrica 3/aabano Terme, Padua (pd) 35031 PMA NumberP950027 Supplement NumberS018 Date Received12/23/2022 Decision Date01/19/2023 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Fidia Farmaceutici S.p.A.via Ponte Della Fabbrica 3/aabano Terme 35031 PMA NumberP180040 Supplement NumberS003 Date Received09/08/2022 Decision Date10/04/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
FIDIA FARMACEUTICI SPAvia Ponte Della Fabbrica 3/aabano Terme, Padua (pd) 35031 PMA NumberP950027 Supplement NumberS017 Date Received09/08/2022 Decision Date10/04/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Fidia Farmaceutici S.p.A.via Ponte Della Fabbrica 3/aabano Terme 35031 PMA NumberP180040 Supplement NumberS002 Date Received07/11/2022 Decision Date08/08/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
FIDIA FARMACEUTICI SPAvia Ponte Della Fabbrica 3/aabano Terme, Padua (pd) 35031 PMA NumberP950027 Supplement NumberS016 Date Received07/11/2022 Decision Date08/08/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
FIDIA FARMACEUTICIponte Della Fabbrica 3/aabano Terme 35031 PMA NumberP150010 Supplement NumberS002 Date Received07/11/2022 Decision Date08/08/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

SEC

0001479105

Fidia Farmaceutici S.p.A. of ITALY

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020082752695	Livorno,Italy -> Savannah, Georgia	ONTO 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
2020072123617	Genova,Italy -> Miami, Florida	ONTO 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, ATLANTA	563 CTN
2020042815365	Genova,Italy -> Savannah, Georgia	ONTO 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 USA	559 CTN
2020032310769	Genova,Italy -> Savannah, Georgia	ONTO 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@DH	225 CTN
2020021733790	Genova,Italy -> Savannah, Georgia	ONTO 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 SULLIV	562 CTN
2019120226982	Genova,Italy -> Savannah, Georgia	ONTO 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 FORWARDING	338 CTN
2019120226983	Genova,Italy -> Savannah, Georgia	ONTO 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 FORWARDIN	557 CTN
2019082643240	La Spezia,Italy -> Savannah, Georgia	HYALGAN 10MG/ML	244 BOX