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18,018 catalysts · 4,728 grant · 3,350 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma
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18,018 catalysts · 4,728 grant · 3,350 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma
Sponsor: SUN PHARM. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: BIONPHARMA. Form: SOLUTION. Route: ORAL
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: STEALTH BIOTHERAPS. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: SUN PHARM INDS. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: SUN PHARM INDS. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: ZYDUS PHARMS USA INC. Form: TABLET. Route: ORAL
Sponsor: XIROMED. Form: INSERT. Route: VAGINAL
Sponsor: ANI PHARMS. Form: TABLET. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: GRAVITI PHARMS. Form: TABLET. Route: ORAL
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: QYE. Advisory committee: Cardiovascular. Type: Traditional
Product code: KDI. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: PZM. Advisory committee: Pathology. Type: Traditional
Product code: MPN. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FDT. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HGM. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: HBE. Advisory committee: Neurology. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: CAF. Advisory committee: Anesthesiology. Type: Traditional
Product code: OWY. Advisory committee: General, Plastic Surgery. Type: Special
Product code: EMA. Advisory committee: Dental. Type: Traditional
Product code: KIF. Advisory committee: Dental. Type: Traditional
Product code: HTY. Advisory committee: Orthopedic. Type: Special
Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: ELC. Advisory committee: Dental. Type: Traditional
Product code: LLL. Advisory committee: Immunology. Type: Traditional
Product code: SFS. Advisory committee: Hematology. Type: Direct
Supplement type: 30-Day Notice. Product code: NHL. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: PYX. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30
Supplement type: Special (Immediate Track). Product code: MAQ. Advisory committee: MI. Decision: APPR
Supplement type: Special (Immediate Track). Product code: NIM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: QQK. Advisory committee: GU. Decision: OK30
Supplement type: Special (Immediate Track). Product code: MKT. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: OZD. Advisory committee: CV. Decision: OK30
Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. Description: ARVIS Shoulder is a computer-controlled surgical navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient s preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments. The device s workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based on the patient s CT reconstructed digital bone model and bony landmarks. The shoulder navigation application software then matches the patient s digital bone model and landmarks to the intraoperative landmarks registered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants. — Reason: Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion. — Status: Ongoing
DxI 9000 Access Immunoassay Analyzer, Part Number C11137 — Reason: Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected. — Status: Ongoing
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030. 2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035. 3. POLYAXIAL SCREW, CC, 5.5mm X 40mm; Item Number: TL1-10755040. 4. POLYAXIAL SCREW, CC, 5.5mm X 45mm; Item Number: TL1-10755045. 5. POLYAXIAL SCREW, CC, 5.5mm X 50mm; Item Number: TL1-10755050. 6. POLYAXIAL SCREW, CC, 6.5mm X 30mm; Item Number: TL1-10765030. 7. POLYAXIAL SCREW, CC, 6.5mm X 35mm; Item Number: TL1-10765035. 8. POLYAXIAL SCREW, CC, 6.5mm X 40mm; Item Number: TL1-10765040. 9. POLYAXIAL SCREW, CC, 6.5mm X 45mm; Item Number: TL1-10765045. 10. POLYAXIAL SCREW, CC, 6.5mm X 50mm; Item Number: TL1-10765050. 11. POLYAXIAL SCREW, CC, 6.5mm X 55mm; Item Number: TL1-10765055. 12. POLYAXIAL SCREW, CC, 6.5mm X 60mm; Item Number: TL1-10765060. 13. POLYAXIAL SCREW, CC, 7.5mm X 30mm; Item Number: TL1-10775030. 14. POLYAXIAL SCREW, CC, 7.5mm X 35mm; Item Number: TL1-10775035. 15. POLYAXIAL SCREW, CC, 7.5mm X 40mm; Item Number: TL1-10775040. 16. POLYAXIAL SCREW, CC, 7.5mm X 45mm; Item Number: TL1-10775045. 17. POLYAXIAL SCREW, CC, 7.5mm X 50mm; Item Number: TL1-10775050. 18. POLYAXIAL SCREW, CC, 7.5mm X 55mm; Item Number: TL1-10775055. 19. POLYAXIAL SCREW, CC, 7.5mm X 60mm; Item Number: TL1-10775060. 20. POLYAXIAL SCREW, CC, 8.5mm X 35mm; Item Number: TL1-10785035. 21. POLYAXIAL SCREW, CC, 8.5mm X 40mm; Item Number: TL1-10785040. 22. POLYAXIAL SCREW, CC, 8.5mm X 45mm; Item Number: TL1-10785045. 23. POLYAXIAL SCREW, CC, 8.5mm X 50mm; Item Number: TL1-10785050. 24. POLYAXIAL SCREW, CC, 8.5mm X 55mm; Item Number: TL1-10785055. 25. POLYAXIAL SCREW, CC, 8.5mm X 60mm; Item Number: TL1-10785060. — Reason: Polyaxial screws do not meet performance standards. — Status: Ongoing