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14,286 catalysts · 3,368 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
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14,286 catalysts · 3,368 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
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
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JAQ. Advisory committee: Radiology. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: PQP. Advisory committee: PA. Decision: APPR
Supplement type: Real-Time Process. Product code: NPW. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: MVK. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: QFV. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LOZ. Advisory committee: CV. Decision: APPR
AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities. — Reason: Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users). — Status: Ongoing