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13,363 catalysts · 3,603 8k filing · 2,401 grant · 2,054 approval · 1,400 device 510k · 1,000 device adverse event · 944 device recall
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13,363 catalysts · 3,603 8k filing · 2,401 grant · 2,054 approval · 1,400 device 510k · 1,000 device adverse event · 944 device recall
Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4. — 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
I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20. — 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
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60. — 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
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6. — 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
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3. — 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
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