AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

NDC#

• Prenate Chewable

  Avion Pharmaceuticals, LLC

  calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin and bilberry

• PRENATE Restore

  Avion Pharmaceuticals, LLC

  ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent

• PRENATE Enhance

  Avion Pharmaceuticals, LLC

  ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent

• PRENATE DHA

  Avion Pharmaceuticals, LLC

  ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent

• Prenate Essential

  Avion Pharmaceuticals, LLC

  ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent

• Prenate Elite

  Avion Pharmaceuticals, LLC

  .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, calcium formate, ferrous asparto glycinate, cyanocobalamin, ...

• Prenate Mini

  Avion Pharmaceuticals, LLC

  ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous asparto glycinate, iron, potassium iodide, magnesium oxide, doconexent and lowbush blueberry

• Prenate Pixie

  Avion Pharmaceuticals, LLC

  ascorbic acid, biotin, cholecalciferol, cyanocobalamin, levomefolate calcium, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, Docosahexaenoic acid, and blueberry

• Chromagen

  Avion Pharmaceuticals, LLC

  ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, zinc, and intrinsic factor

• Nicomide

  Avion Pharmaceuticals, LLC

  niacinamide, zinc glycinate, folic acid, cupric oxide, selenium and chromium

• Niferex

  Avion Pharmaceuticals, LLC

  ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, and succinic acid

• Balcoltra

  Avion Pharmaceuticals

  levonorgestrel and ethinyl estradiol

• AVERI

  Avion Pharmaceuticals, LLC

  desogestrel and ethinyl estradiol

• Dhivy

  Avion Pharmaceuticals, LLC

  Carbidopa Levodopa

• LACRIFRESH HYDRAPF

  AVIZOR, S.A.

  Glycerin, Povidone

• LACRIFRESH HYDRAMAXPF

  AVIZOR, S.A.

  Glycerin, Povidone

PMA#

• Avive Automated External Defibrillator (AED) System

  2022-10-31

  Avive Solutions, Inc.223 Mississippi Street, Unit 2san Francisco, CA 94107 PMA NumberP210015 Date Received04/06/2021 Decision Date10/31/2022 Product Code MKJ  Advisory Committee Cardiovascular Expedited Review Granted? No

PMN#

• Nasal Aspirator (NS 13)

  2024-12-31

  Avita Corporation

• Arm Type Blood Pressure Monitor (BPM82)

  2024-10-22

  Avita Corporation

• CINA-CSpine

  2024-09-12

  Avicenna.Ai

• CINA-VCF

  2024-05-31

  Avicenna.Ai

• AViTA Pulse Oximeter

  2024-05-20

  Avita Corporation

• CINA-ASPECTS

  2024-03-15

  Avicenna.Ai

• CINA-iPE

  2024-03-13

  Avicenna.Ai

• Vivio® LVEDP System

  2023-10-06

  Avicena, LLC

• Avitus® DragonWing Large Volume Autograft Delivery System

  2023-07-17

  Avitus Orthopaedics, Inc.

• Avitus® Precision Autograft Delivery System

  2023-06-26

  Avitus Orthopaedics, Inc.

• Pantheris LV Atherectomy Catheter

  2023-06-06

  Avinger, Inc.

• Tigereye ST CTO-Crossing Catheter

  2023-04-25

  Avinger, Inc.

• CINA

  2022-11-22

  Avicenna.Ai

• 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)

  2022-07-14

  AVIA Vascular

• Tigereye CTO-Crossing Catheter

  2022-01-06

  Avinger, Inc.

• Pantheris System

  2021-11-16

  Avinger, Inc.

• Automatic Digital Blood Pressure Monitor

  2021-09-23

  AVICHE Shandong Medical Technology Co, Ltd.

• CINA CHEST

  2021-05-19

  Avicenna.AI

• Avitus(r) Bone Harvester

  2021-03-31

  Avitus Orthopaedics, Inc.

• Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes

  2021-03-01

  Avinent Implant System S.L.U.

• Wrist Type Blood Pressure Monitor

  2020-12-17

  Avita Corporation

• Tigereye CTO-Crossing Catheter

  2020-09-10

  Avinger, Inc.

• CINA

  2020-06-24

  AVICENNA.AI

• Avinent Surgical Tray

  2020-03-06

  AVINENT Implant System, S.L.U.

• Vivio System

  2019-10-04

  Avicena LLC

• Pantheris SV

  2019-04-09

  Avinger, Inc.

• Arm Type Blood Pressure Monitor

  2018-08-03

  Avita Corporation

• Pantheris System

  2018-05-22

  Avinger, Inc.

• AViTA Radar Thermo NT16 Series IR Thermometer

  2018-04-19

  Avita Corporation

• Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled

  2017-10-30

  Avinger, Inc.

• Avitus Bone Harvester With Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester With Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm

  2017-03-20

  Avitus Orthopaedics, Inc

• Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled

  2016-12-21

  Avinger, Inc.

• Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled

  2016-10-18

  Avinger, Inc

• Pantheris Catheter

  2016-04-21

  AVINGER, INC.

• Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)

  2016-03-01

  AVINGER, INC.

• Avitus Bone Harvester

  2015-10-23

  Avitus Orthopaedics Inc.

• Pantheris System

  2015-10-14

  Avinger, Inc.

• OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE

  2014-05-01

  AVINGER, INC.

• AVINENT DENTAL IMPLANT SYSTEM

  2013-12-11

  AVINENT IMPLANT SYSTEM, S.L.

• OCELOT PIXL CATHETER

  2012-12-14

  AVINGER, INC.

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Applications#

• 218933

  AVION PHARMS

• 212123

  AVID RADIOPHARMS INC

• 210942

  AVION PHARMS

• 208612

  AVION PHARMS

• 202008

  AVID RADIOPHARMS INC