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13,507 catalysts · 3,368 8k filing · 2,401 grant · 2,136 approval · 1,479 device 510k · 1,105 device recall · 1,000 device adverse event
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13,507 catalysts · 3,368 8k filing · 2,401 grant · 2,136 approval · 1,479 device 510k · 1,105 device recall · 1,000 device adverse event
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
Supplement type: Real-Time Process. Product code: NIP. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: OWO. Advisory committee: EN. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: Real-Time Process. Product code: NIM. Advisory committee: CV. Decision: APPR
Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901 — Reason: It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results. — Status: Ongoing
Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument — Reason: Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction — Status: Ongoing
Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR
Product code: DQX. Advisory committee: Cardiovascular. Type: Special