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20,727 catalysts · 4,728 grant · 3,345 8k filing · 3,312 device 510k · 2,841 approval · 2,000 device pma · 2,000 device recall
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20,727 catalysts · 4,728 grant · 3,345 8k filing · 3,312 device 510k · 2,841 approval · 2,000 device pma · 2,000 device recall
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MTG. Advisory committee: IM. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVY. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: MVK. Advisory committee: CV. Decision: OK30
Pentax Medical Video Processor; Model Number: EPK-i8020c; — Reason: During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane. — Status: Ongoing
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889. — Reason: Potential for missing pins at tip of inserter. — Status: Ongoing
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system. — Reason: The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with the system and preventing use which causes a delay in obtaining patient results. — Status: Ongoing
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NQQ. Advisory committee: Radiology. Type: Traditional
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ODC. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Special
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: GZF. Advisory committee: Neurology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: Special (Immediate Track). Product code: NIM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A — Reason: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction — Status: Ongoing
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A — Reason: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction — Status: Ongoing
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component — Reason: Measles IgM Test Kit lacks premarket approval or clearance. — Status: Ongoing
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and rods. The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. — Reason: Due to out of the box wobble of the driver. — Status: Ongoing
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216 — Reason: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction — Status: Ongoing
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029 — Reason: Surgical drape packs may have open seals, which may compromise the sterility of the product. — Status: Ongoing
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software — Reason: Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) , — Status: Ongoing
Product code: JFT. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: MOS. Advisory committee: Radiology. Type: Abbreviated
Product code: DQO. Advisory committee: Cardiovascular. Type: Traditional
Product code: MUD. Advisory committee: Cardiovascular. Type: Traditional
Product code: JXI. Advisory committee: Neurology. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: EIA. Advisory committee: Dental. Type: Special
Product code: MOF. Advisory committee: Cardiovascular. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Traditional