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10,371 catalysts · 3,301 8k filing · 2,097 grant · 1,166 approval · 1,000 device adverse event · 881 device 510k · 629 device pma
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10,371 catalysts · 3,301 8k filing · 2,097 grant · 1,166 approval · 1,000 device adverse event · 881 device 510k · 629 device pma
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
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: EFB. Advisory committee: Dental. Type: Traditional
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
Product code: EFB. Advisory committee: Dental. Type: Traditional
Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EBW. Advisory committee: Dental. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QHE. Advisory committee: Orthopedic. Type: Traditional
Product code: KIF. Advisory committee: Dental. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: Panel Track. Product code: QZI. Advisory committee: CV. Decision: APPR