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14,968 catalysts · 3,603 8k filing · 2,670 grant · 2,420 approval · 1,702 device 510k · 1,263 device recall · 1,164 device pma
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14,968 catalysts · 3,603 8k filing · 2,670 grant · 2,420 approval · 1,702 device 510k · 1,263 device recall · 1,164 device pma
AG grant. $716,579. PI: Erik Bradley Bloss
DC grant. $41,394. PI: Bao Le
AG grant. $639,838. PI: MARC D TAMBINI
AG grant. $659,309. PI: Tatiana V Byzova
AG grant. $429,394. PI: Shawn Brady Bender
Sponsor: APOTEX INC. Form: CAPSULE. Route: ORAL
Sponsor: PFIZER INC. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: GLAXOSMITHKLINE LLC. Form: INJECTION
Sponsor: NOVITIUM PHARMA. Form: SYRUP. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: SPRAY, METERED. Route: NASAL
Sponsor: ALEMBIC PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL
Sponsor: IBSA. Form: FILM. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL
Sponsor: AMNEAL IRELAND LTD. Form: AEROSOL, METERED. Route: INHALATION
Sponsor: ALEMBIC PHARMS LTD. Form: TABLET. Route: ORAL
Product code: OVK. Advisory committee: Immunology. Type: Traditional
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DXQ. Advisory committee: Cardiovascular. Type: Traditional
Product code: LJS. Advisory committee: General Hospital. Type: Traditional
Product code: SCV. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GAM. Advisory committee: General, Plastic Surgery. Type: Special
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HSX. Advisory committee: Orthopedic. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: PPW. Advisory committee: Cardiovascular. Type: Traditional
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: QLR. Advisory committee: Orthopedic. Type: Traditional
Product code: QPC. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NUU. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: PFV. Advisory committee: CV. Decision: OK30
Supplement type: Special (Immediate Track). Product code: QQK. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: LZP. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MWL. Advisory committee: OP. Decision: OK30
Supplement type: Panel Track. Product code: SGU. Advisory committee: NE. Decision: APPR
Supplement type: Special (Immediate Track). Product code: QBA. Advisory committee: GU. Decision: APPR
Supplement type: Special (Immediate Track). Product code: QIK. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G — Reason: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use. — Status: Ongoing
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927. — Reason: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use. — Status: Ongoing
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25 — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B — Reason: XXX — Status: Ongoing