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18,023 catalysts · 4,728 grant · 3,603 8k filing · 2,594 approval · 1,952 device 510k · 1,578 device recall · 1,359 device pma
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18,023 catalysts · 4,728 grant · 3,603 8k filing · 2,594 approval · 1,952 device 510k · 1,578 device recall · 1,359 device pma
Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
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