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12,383 catalysts · 3,603 8k filing · 2,369 grant · 1,782 approval · 1,176 device 510k · 1,000 device adverse event · 851 device pma
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12,383 catalysts · 3,603 8k filing · 2,369 grant · 1,782 approval · 1,176 device 510k · 1,000 device adverse event · 851 device pma
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: MQC. Advisory committee: Unknown. Type: Traditional
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
Product code: FFX. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DXH. Advisory committee: Cardiovascular. Type: Traditional
Product code: KLE. Advisory committee: Dental. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: MYE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: PBF. Advisory committee: Orthopedic. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: KXK. Advisory committee: Radiology. Type: Traditional
Product code: JTN. Advisory committee: Microbiology. Type: Traditional
Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: OAD. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: LPM. Advisory committee: OP. Decision: APPR
Supplement type: Real-Time Process. Product code: MIH. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30
Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30
Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30
BVI Leos Laser and Endoscopy System. Model Number: OME6000U. — Reason: Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable). — Status: Ongoing
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300 — Reason: The affected lots show a decline in performance over time, which may lead to false-negative results. — Status: Ongoing
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 — Reason: A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect. — Status: Ongoing
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23 — Reason: Incorrect expiration date — Status: Ongoing
AI grant. $49,538. PI: Amber Bahr
HD grant. $45,988. PI: Julia Marie Hartman
HL grant. $241,702. PI: MEI-ZHEN CUI
Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION
Sponsor: LANNETT CO INC. Form: TABLET. Route: ORAL
Sponsor: LANNETT CO INC. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: TEVA PHARMS USA INC. Form: INSERT. Route: VAGINAL
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: POK. Advisory committee: Radiology. Type: Traditional
Product code: DXH. Advisory committee: Cardiovascular. Type: Traditional
Product code: JOW. Advisory committee: Cardiovascular. Type: Traditional
Product code: OVD. Advisory committee: Orthopedic. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NCG. Advisory committee: Neurology. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Abbreviated
Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30
Supplement type: Real-Time Process. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30
Product code: JXK. Advisory committee: NE. Decision: APPR
Supplement type: Panel Track. Product code: SGU. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30