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12,103 catalysts · 3,603 8k filing · 2,280 grant · 1,746 approval · 1,120 device 510k · 1,000 device adverse event · 821 device pma
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12,103 catalysts · 3,603 8k filing · 2,280 grant · 1,746 approval · 1,120 device 510k · 1,000 device adverse event · 821 device pma
Sponsor: HIBROW HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: ENCUBE. Form: CREAM. Route: TOPICAL
Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION
Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION
Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: HIKMA. Form: TABLET. Route: ORAL
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: KDI. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: LRX. Advisory committee: Ophthalmic. Type: Traditional
Product code: MOS. Advisory committee: Radiology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: ETN. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: JDW. Advisory committee: Orthopedic. Type: Special
Product code: MJV. Advisory committee: Unknown. Type: Traditional
Product code: OVB. Advisory committee: Radiology. Type: Special
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: LPO. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: LZP. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
Supplement type: Panel Track. Product code: NAW. Advisory committee: RA. Decision: APPR
Supplement type: Panel Track. Product code: PLS. Advisory committee: PA. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Product code: NUU. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVY. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: OJX. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: LPO. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System — Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) — Status: Ongoing
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System — Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) — Status: Ongoing
Artegraft Vascular Graft; REF#: AG740; — Reason: Labeling mix-up resulting in the incorrect lot outer packaging of product. — Status: Ongoing
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000; — Reason: Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit. — Status: Ongoing