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49 catalysts · 19 device pma · 12 device 510k · 10 approval · 7 device recall · 1 grant
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49 catalysts · 19 device pma · 12 device 510k · 10 approval · 7 device recall · 1 grant
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
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200 — 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 DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845 — 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
Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A — 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
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system. — Reason: Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices. — Status: Ongoing
GM grant. $140,056. PI: Ruby Fried