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12,946 catalysts · 3,393 8k filing · 2,377 grant · 2,035 approval · 1,373 device 510k · 1,000 device adverse event · 929 device pma
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12,946 catalysts · 3,393 8k filing · 2,377 grant · 2,035 approval · 1,373 device 510k · 1,000 device adverse event · 929 device pma
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: GRANULES. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL
Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL
Sponsor: PH HEALTH. Form: SOLUTION. Route: ORAL
Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION
Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL
Sponsor: TELIX. Form: POWDER. Route: INTRAVENOUS
Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: SHREE HARI INTL. Form: SYRUP. Route: ORAL
Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: INSMED INC. Form: SUSPENSION, LIPOSOMAL. Route: INHALATION
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: NPL. Advisory committee: Dental. Type: Traditional
Product code: QKB. Advisory committee: Radiology. Type: Traditional
Product code: FAS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Special
Product code: ONB. Advisory committee: General Hospital. Type: Special
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
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