SEIKAGAKU CORPORATION, TAKAHAGI PLANT

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• xxx.xxx

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• Gel-One

  2023-01-05

  SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS051 Date Received12/08/2022 Decision Date01/05/2023 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process ...

• Gel-One

  2022-10-19

  SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS049 Date Received09/20/2022 Decision Date10/19/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process ...

• Gel-One

  2022-07-22

  SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS048 Date Received06/22/2022 Decision Date07/22/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process ...

• GEL-ONE

  2022-03-31

  SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS047 Date Received03/03/2022 Decision Date03/31/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process ...

• Suparts FX & Visco-3

  2022-03-31

  SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP980044 Supplement NumberS059 Date Received03/02/2022 Decision Date03/31/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process ...

• Gel-One

  2021-11-17

  SEIKAGAKU CORP.

• SUPARTZ FX, VISCO-3

  2021-11-17

  SEIKAGAKU CORP.

• GEL-ONE

  2021-10-04

  SEIKAGAKU CORP.

• Gel-One

  2021-08-06

  SEIKAGAKU CORP.

• SUPARTZ FX and VISCO-3

  2021-08-06

  SEIKAGAKU CORP.

• Gel-One

  2021-05-26

  SEIKAGAKU CORP.

• SUPARTZ device family, SUPARTZ FX and VISCO-3

  2021-05-24

  SEIKAGAKU CORP.

• Gel-One

  2021-04-15

  SEIKAGAKU CORP.

• SUPARTZ device family, SUPARTZ FX and VISCO-3

  2021-04-15

  SEIKAGAKU CORP.

• Gel-One

  2020-11-17

  SEIKAGAKU CORP.

• Gel-One

  2020-11-12

  SEIKAGAKU CORP.

• SUPARTZ FX, VISCO-3

  2020-11-12

  SEIKAGAKU CORP.

• SUPARTZ FX and VISCO-3

  2020-07-17

  SEIKAGAKU CORP.

• Gel-One

  2020-07-17

  SEIKAGAKU CORP.

• Gel-One

  2020-03-31

  SEIKAGAKU CORP.

• Gel-One

  2020-03-16

  SEIKAGAKU CORP.

• Gel-One

  2019-10-30

  SEIKAGAKU CORP.

• Gel-One

  2019-03-13

  SEIKAGAKU CORP.

• Gel-One

  2019-03-13

  SEIKAGAKU CORP.

• SUPARTZ FX; VISCO-3

  2019-01-18

  SEIKAGAKU CORP.

• Gel-One

  2018-12-06

  SEIKAGAKU CORP.

• Supartz FX and Visco-3

  2018-12-06

  SEIKAGAKU CORP.

• SUPARTZ FX/VISCO-3

  2018-11-13

  SEIKAGAKU CORP.

• SUPARTZ FX and VISCO-3

  2018-08-16

  SEIKAGAKU CORP.

• Gel-One

  2018-08-07

  SEIKAGAKU CORP.

• SUPARTZ FX and VISCO-3

  2018-08-07

  SEIKAGAKU CORP.

• Supartz FX, Visco-3

  2018-06-08

  SEIKAGAKU CORP.

• Supartz FX, Visco-3

  2018-05-25

  SEIKAGAKU CORP.

• GEL-ONE

  2018-03-15

  SEIKAGAKU CORP.

• SUPARTZ FX and VISCO-3

  2018-03-15

  SEIKAGAKU CORP.

• Gel-One

  2018-03-14

  SEIKAGAKU CORP.

• Supartz FX and Visco-3

  2018-03-14

  SEIKAGAKU CORP.

• Gel-One

  2018-02-09

  SEIKAGAKU CORP.

• SUPARTZ FX and VISCO-3

  2018-02-09

  SEIKAGAKU CORP.

• Gel-One

  2017-12-14

  SEIKAGAKU CORP.

105 records. Showing 1-40. Next

PMN#

• HADGEL, 4 GRAM/SYRINGE

  2001-08-15

  SEIKAGAKU CORP.

GUDID#

• VISCO-3 sodium hyaluronate - VISCO-3 (P980044/S027) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.VISCO-3 is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. VISCO-3 is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).

  SEIKAGAKU CORPORATION

  2017-03-22

• SUPARTZ FX sodium hyaluronate - SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).

  SEIKAGAKU CORPORATION

  2017-01-31

• Gel-One® Cross-linked Hyaluronate - Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.

  SEIKAGAKU CORPORATION

  2020-01-15

• Gel-One® Cross-linked Hyaluronate - Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.

  SEIKAGAKU CORPORATION

  2014-09-17

• SUPARTZ® sodium hyaluronate - SUPARTZ (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from rooster combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).

  SEIKAGAKU CORPORATION

  2017-01-31