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19,907 catalysts · 4,728 grant · 3,350 8k filing · 2,785 device 510k · 2,724 approval · 2,000 device recall · 1,962 device pma
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19,907 catalysts · 4,728 grant · 3,350 8k filing · 2,785 device 510k · 2,724 approval · 2,000 device recall · 1,962 device pma
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Traditional
Product code: QNQ. Advisory committee: General Hospital. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Special
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: OBP. Advisory committee: Neurology. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: KRA. Advisory committee: Cardiovascular. Type: Traditional
Product code: OVE. Advisory committee: Orthopedic. Type: Traditional
Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL
Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: Real-Time Process. Product code: QKF. Advisory committee: PA. Decision: APPR
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover Component: Lumicell Direct Visualization System (DVS) / PMA # P230014 — Reason: The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies in the surgical cavity and potentially leading to surgical site infections. — Status: Ongoing
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH 401915RH 401918RH 401932RH 401933RH 401934RH 401938RH 401939RH 401940RH 401941RH 401991RH — Reason: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. — Status: Ongoing
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH — Reason: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. — Status: Ongoing
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 81104RH 81107RH 81174RH 81402RH 81404RH 81405RH 81472RH 81473RH 81474RH 81531RH 81532RH — Reason: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. — Status: Ongoing
Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. Medline Item Numbers 10135910RH 10135936RH — Reason: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. — Status: Ongoing
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50 — Reason: Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. — Status: Ongoing
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH — Reason: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. — Status: Ongoing
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: KWZ. Advisory committee: Orthopedic. Type: Traditional
Product code: JDI. Advisory committee: Orthopedic. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Special
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: QDQ. Advisory committee: Radiology. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Traditional
Product code: ONG. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: SBF. Advisory committee: Neurology. Type: Traditional
Product code: LEL. Advisory committee: Neurology. Type: Special
Product code: SFH. Advisory committee: Pathology. Type: Direct
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: MSX. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: SANDOZ. Form: TABLET. Route: ORAL
Sponsor: SANDOZ. Form: TABLET. Route: ORAL
Sponsor: SANDOZ. Form: TABLET. Route: ORAL
Sponsor: PFIZER. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Supplement type: Normal 180 Day Track No User Fee. Product code: OZD. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: PYX. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MRA. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: Real-Time Process. Product code: OAE. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30