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13,358 catalysts · 3,382 8k filing · 2,401 grant · 2,076 approval · 1,436 device 510k · 1,072 device recall · 1,000 device adverse event
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13,358 catalysts · 3,382 8k filing · 2,401 grant · 2,076 approval · 1,436 device 510k · 1,072 device recall · 1,000 device adverse event
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: AZURITY. Form: SOLUTION. Route: ORAL
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: ARROWHEAD. Form: SOLUTION. Route: SUBCUTANEOUS
Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: GXQ. Advisory committee: Neurology. Type: Traditional
Product code: IZQ. Advisory committee: Cardiovascular. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HIS. Advisory committee: Obstetrics/Gynecology. Type: Abbreviated
Product code: QRX. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: LGZ. Advisory committee: General Hospital. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: DXH. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: Real-Time Process. Product code: MVK. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: QAN. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: FWM. Advisory committee: SU. Decision: APPR
HemosIL SynthAFax. Partial Thromboplastin Time Tests. — Reason: Recalled lots were manufactured with double the amount of preservative concentration. — Status: Ongoing
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1) — Reason: When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing. — Status: Ongoing
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800 — Reason: It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled. — Status: Ongoing
Intelerad InteleShare software, with ProViewer component — Reason: Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up. — Status: Ongoing
AG grant. $746,114. PI: Jennifer Villwock
Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: HIBROW HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: HETERO LABS LTD V. Form: CAPSULE. Route: ORAL
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION
Sponsor: DR REDDYS. Form: CAPSULE. Route: ORAL
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: BIOXCEL. Form: FILM. Route: BUCCAL, SUBLINGUAL
Sponsor: MSN. Form: CAPSULE. Route: ORAL
Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL
Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL
Sponsor: BAYER HEALTHCARE. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: QUT. Advisory committee: Microbiology. Type: Traditional
Product code: PBF. Advisory committee: Orthopedic. Type: Traditional
Product code: SGR. Advisory committee: Anesthesiology. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PLP. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional