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18,580 catalysts · 4,728 grant · 3,350 8k filing · 2,650 approval · 2,236 device 510k · 1,799 device recall · 1,552 device pma
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18,580 catalysts · 4,728 grant · 3,350 8k filing · 2,650 approval · 2,236 device 510k · 1,799 device recall · 1,552 device pma
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL
Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: NRA. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKT. Advisory committee: MI. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NRA. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: OAE. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
FloPatch FP120, REF: FP120-FOT01-005 — Reason: Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20. — Status: Ongoing
Product code: QPL. Advisory committee: Neurology. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: GXD. Advisory committee: Neurology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: QEB. Advisory committee: Anesthesiology. Type: Traditional
Sponsor: AMNEAL. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL
Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS
Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS
Supplement type: 30-Day Notice. Product code: NIU. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NXW. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: OZD. Advisory committee: CV. Decision: APPR
Product code: MNQ. Advisory committee: AN. Decision: APPR
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: PNK. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: FWM. Advisory committee: SU. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: PQP. Advisory committee: PA. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIO. Advisory committee: CV. Decision: OK30
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set — Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation. — Status: Ongoing
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Software Version: 12.0.4.12. 5. RayStation 11B Service Pack Toshiba 1, Software Version: 12.3.0.119. Product Description: Radiation Therapy Treatment Planning System. — Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. — Status: Ongoing
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113. 5. RayStation 9A Service Pack 1, Software Version: 9.0.1.142. Product Description: Radiation Therapy Treatment Planning System. — Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. — Status: Ongoing
IntelliSpace Cardiovascular, Software 8.0.0.4. — Reason: Software issue that results in the display of outdated information. — Status: Ongoing
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006 — Reason: Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range. — Status: Ongoing
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B — Reason: Convenience kits labeled as sterile have not gone through the sterilization process. — Status: Ongoing
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3, Software Version: 11.0.4.15. Product Description: Radiation Therapy Treatment Planning System. — Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. — Status: Ongoing
RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software Version: 10.0.0.1154. 4. RayStation 10A Service Pack 1, Software Version: 10.0.1.52. 5. RayStation 10A Service Pack 2, Software Version: 10.0.2.10. Product Description: Radiation Therapy Treatment Planning System. — Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. — Status: Ongoing
RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation Therapy Treatment Planning System. — Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. — Status: Ongoing
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B — Reason: Convenience kits labeled as sterile have not gone through the sterilization process. — Status: Ongoing
RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System. — Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. — Status: Ongoing
RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Therapy Treatment Planning System. — Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. — Status: Ongoing