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13,661 catalysts · 3,350 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma
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13,661 catalysts · 3,350 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma
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
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION
Sponsor: COSETTE PHARMS NC. Form: SUSPENSION/DROPS. Route: OTIC
Sponsor: ELITE LABS INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: GRANULES INDIA. Form: TABLET. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: POWDER. Route: INTRAVENOUS
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: COHERUS BIOSCIENCES INC. Form: INJECTABLE. Route: INJECTION
Product code: NRY. Advisory committee: Cardiovascular. Type: Traditional
Product code: PLR. Advisory committee: Orthopedic. Type: Traditional
Product code: SAQ. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GXN. Advisory committee: Neurology. Type: Traditional
Product code: MUH. Advisory committee: Dental. Type: Special
Product code: MHX. Advisory committee: Cardiovascular. Type: Traditional
Product code: DPS. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: Real-Time Process. Product code: DYE. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: MOM. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LWR. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: DYE. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LWR. Advisory committee: CV. Decision: APPR
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent. — Reason: Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. — Status: Ongoing
ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. — Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. — Status: Ongoing
ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. — Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. — Status: Ongoing
ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. — Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. — Status: Ongoing
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices. — Reason: The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component. — Status: Ongoing
ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. — Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. — Status: Ongoing