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10,224 catalysts · 3,138 8k filing · 2,098 grant · 1,170 approval · 1,000 device adverse event · 885 device 510k · 633 device pma
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10,224 catalysts · 3,138 8k filing · 2,098 grant · 1,170 approval · 1,000 device adverse event · 885 device 510k · 633 device pma
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
Sponsor: EMERGENT. Form: SPRAY, METERED. Route: NASAL
Sponsor: ABHAI LLC. Form: SOLUTION. Route: ORAL
Sponsor: UNIQUE PHARM. Form: TABLET. Route: ORAL
Sponsor: UMEDICA. Form: TABLET. Route: ORAL
Sponsor: BIOCON PHARMA. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL
Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL
Sponsor: SUNNY. Form: INJECTABLE. Route: INJECTION
Product code: MHX. Advisory committee: Cardiovascular. Type: Traditional
Product code: CGX. Advisory committee: Clinical Chemistry. Type: Dual Track
Product code: PHX. Advisory committee: Orthopedic. Type: Special
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: SBF. Advisory committee: Neurology. Type: Traditional
Product code: QQH. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Special
Product code: DXQ. Advisory committee: Cardiovascular. Type: Special
Product code: KPE. Advisory committee: General Hospital. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Special
Product code: CIX. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: OXC. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GFO. Advisory committee: Hematology. Type: Special
Product code: SAH. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: 135 Review Track For 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable. — Reason: Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. — Status: Ongoing
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3) — Reason: It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke. — Status: Ongoing
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable. — Reason: Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. — Status: Ongoing
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720; — Reason: Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised. — Status: Ongoing
GM grant. $312,417. PI: Dorian R Dodd
AI grant. $39,066. PI: Brooke Ring
Product code: GWF. Advisory committee: Neurology. Type: Traditional
Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL
Sponsor: ASCENT PHARMS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: RESPIRENT PHARMS. Form: POWDER. Route: INHALATION
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION
Sponsor: SENTYNL THERAPS INC. Form: POWDER. Route: SUBCUTANEOUS