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12,869 catalysts · 3,316 8k filing · 2,377 grant · 2,035 approval · 1,373 device 510k · 1,000 device adverse event · 929 device pma
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12,869 catalysts · 3,316 8k filing · 2,377 grant · 2,035 approval · 1,373 device 510k · 1,000 device adverse event · 929 device pma
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: AMNEAL. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: HERITAGE PHARMA. Form: TABLET. Route: ORAL
Sponsor: INVAGEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: ACTAVIS LABS FL INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: IZF. Advisory committee: Radiology. Type: Traditional
Product code: OXO. Advisory committee: Radiology. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Abbreviated
Product code: QAS. Advisory committee: Radiology. Type: Special
Product code: QFG. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: HBL. Advisory committee: Neurology. Type: Traditional
Product code: DXX. Advisory committee: Cardiovascular. Type: Traditional
Product code: KWS. Advisory committee: Orthopedic. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HBE. Advisory committee: Neurology. Type: Traditional
Product code: KLE. Advisory committee: Dental. Type: Traditional
Supplement type: Normal 180 Day Track No User Fee. Product code: MNQ. Advisory committee: AN. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: NQR. Advisory committee: NE. Decision: APPR
Supplement type: Real-Time Process. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: Special (Immediate Track). Product code: NGV. Advisory committee: CV. Decision: APPR
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630 — Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. — Status: Ongoing
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) — Reason: Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome. — Status: Ongoing
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 — Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. — Status: Ongoing
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426 — Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. — Status: Ongoing
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, — Reason: Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels. — Status: Ongoing
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications. — Reason: Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network — Status: Ongoing
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826 — Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. — Status: Ongoing
Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: OBP. Advisory committee: Neurology. Type: Traditional
Product code: JEY. Advisory committee: Dental. Type: Traditional
Product code: QWO. Advisory committee: Radiology. Type: Traditional
Product code: NXC. Advisory committee: Dental. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: IZQ. Advisory committee: Cardiovascular. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: HKX. Advisory committee: Ophthalmic. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: PMP. Advisory committee: NE. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: Real-Time Process. Product code: NQR. Advisory committee: NE. Decision: APPR