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12,251 catalysts · 3,603 8k filing · 2,283 grant · 1,771 approval · 1,164 device 510k · 1,000 device adverse event · 848 device pma
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12,251 catalysts · 3,603 8k filing · 2,283 grant · 1,771 approval · 1,164 device 510k · 1,000 device adverse event · 848 device pma
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
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: MFK. Advisory committee: OP. Decision: OK30
Supplement type: Special (Immediate Track). Product code: NIO. Advisory committee: CV. Decision: APPR
Endo-Model Replacement Plateau; Item Number: 15-0027/11; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-8030/12; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-8521/15; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-0027/15; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-2835/12; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-2836/11; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-8521/09; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-8521/11; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-0027/12; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-0027/16; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
AI grant. $75,052. PI: Sarah C Feid
GM grant. $132,469. PI: Martha Rojo
HD grant. $248,995. PI: Thoa Khuu
NS grant. $579,610. PI: Pau Castel
HL grant. $469,049. PI: nagendra monangi
HL grant. $154,846. PI: HELAINE E. RESNICK