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12,112 catalysts · 3,431 8k filing · 2,283 grant · 1,778 approval · 1,169 device 510k · 1,000 device adverse event · 849 device pma
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12,112 catalysts · 3,431 8k filing · 2,283 grant · 1,778 approval · 1,169 device 510k · 1,000 device adverse event · 849 device pma
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005 — Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products. — Status: Ongoing
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108 — Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products. — Status: Ongoing
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. — Reason: Devices which did not undergo thermoforming could deform and lose performance. — Status: Ongoing
Spectral CT 7500 on Rails; Product Code (REF): 728334; — Reason: As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled. — Status: Ongoing
CA grant. $49,538. PI: Hina Shah
NS grant. $567,047. PI: David Matthew Smith
Sponsor: XCOVERY. Form: CAPSULE. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL
Sponsor: STRIDES PHARMA. Form: TABLET. Route: ORAL
Sponsor: MICRO LABS. Form: POWDER. Route: ORAL
Sponsor: TORRENT. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: FDC LTD. Form: TABLET. Route: ORAL
Sponsor: MICRO LABS. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL
Product code: KNG. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Special
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: FLL. Advisory committee: General Hospital. Type: Traditional
Product code: DRF. Advisory committee: Cardiovascular. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: NDC. Advisory committee: Anesthesiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LPO. Advisory committee: OP. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: OAE. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: MRA. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: OAE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIO. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LPO. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: OAD. Advisory committee: CV. Decision: OK30
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746 — Reason: Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body. — Status: Ongoing
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167 — Reason: Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body. — Status: Ongoing
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSIS CHANGE KIT SKU EBSI1453A Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741 — Reason: Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body. — Status: Ongoing