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9,817 catalysts · 3,312 8k filing · 2,051 grant · 1,024 approval · 1,000 device adverse event · 741 device 510k · 584 earnings
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9,817 catalysts · 3,312 8k filing · 2,051 grant · 1,024 approval · 1,000 device adverse event · 741 device 510k · 584 earnings
Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314. — Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). — Status: Ongoing
NS grant. $577,611. PI: Shella D Keilholz
DK grant. $859,998. PI: ROSEMARY V SAMPOGNA
Sponsor: PH HEALTH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: PH HEALTH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: ACTAVIS LABS FL INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: ACTAVIS LABS FL INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: ACTAVIS LABS FL INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: TEVA. Form: TABLET. Route: ORAL
Sponsor: TEVA. Form: TABLET. Route: ORAL
Sponsor: TEVA. Form: TABLET. Route: ORAL
Sponsor: RISING. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL
Sponsor: RISING. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL
Sponsor: RISING. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL
Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL
Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL
Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL
Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL
Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL
Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL
DA grant. $54,538. PI: Anna Patterson
Sponsor: GRAVITI PHARMS. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: CREAM. Route: TOPICAL
Sponsor: APOTEX. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: CAPLIN. Form: INJECTABLE. Route: INJECTION
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: TEVA. Form: TABLET. Route: ORAL
Sponsor: MSN. Form: INJECTABLE. Route: INJECTION
Sponsor: I 3 PHARMS. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: EMULSION. Route: OPHTHALMIC
Sponsor: NOVITIUM PHARMA. Form: SOLUTION. Route: ORAL
Sponsor: ACCORD HLTHCARE. Form: POWDER. Route: INTRAVENOUS
Sponsor: RISING. Form: CAPSULE, DELAYED RELEASE. Route: ORAL
Sponsor: SOLUBIOMIX. Form: SOLUTION. Route: ORAL
Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION
Product code: KDI. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: DPS. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: NCD. Advisory committee: MI. Decision: APPR
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X — Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. — Status: Ongoing
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X — Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. — Status: Ongoing
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X — Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. — Status: Ongoing
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X — Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. — Status: Ongoing
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X — Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. — Status: Ongoing
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X — Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. — Status: Ongoing
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X — Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. — Status: Ongoing
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X — Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. — Status: Ongoing