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10,380 catalysts · 3,310 8k filing · 2,097 grant · 1,166 approval · 1,000 device adverse event · 881 device 510k · 629 device pma
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10,380 catalysts · 3,310 8k filing · 2,097 grant · 1,166 approval · 1,000 device adverse event · 881 device 510k · 629 device pma
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
HL grant. $129,024. PI: DEDRA S BUCHWALD
AI grant. $87,244. PI: Jenny Ann Buczek
Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL
Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: AMNEAL. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION
Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION
Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL
Sponsor: ZYDUS LIFESCIENCES. Form: SUSPENSION. Route: ORAL
Product code: QNI. Advisory committee: Orthopedic. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Special
Product code: EJK. Advisory committee: Dental. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MVK. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: PMP. Advisory committee: NE. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: LNM. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 — Reason: During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. — Status: Ongoing
Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152; — Reason: units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M. — Status: Ongoing
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A — Reason: Pumps were released without full testing being performed, including occlusion alarm testing. — Status: Ongoing
DK grant. $450,479. PI: Zhijian Qian