Calendar

pharmadog

Week of Oct 28, 2024

Oct 30, 2024device 510k652d agoRemedy Logic, Inc. — RemedyLogic AI MRI Lumbar Spine Reader (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Oct 30, 2024device 510k652d agoSonomotion, Inc. — Stone Clear (SC-LP9-01) (510k cleared)

Product code: QNA. Advisory committee: Gastroenterology, Urology. Type: Direct

full page →fda device 510k ↗

Oct 30, 2024device 510k652d agoSiemens Medical Solutions USA, Inc. — Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family (510k cleared)

Product code: KPS. Advisory committee: Radiology. Type: Special

full page →fda device 510k ↗

Oct 30, 2024device 510k652d agoMicrogenics Corporation — DRI Ecstasy Plus Assay (510k cleared)

Product code: DKZ. Advisory committee: Clinical Toxicology. Type: Special

full page →fda device 510k ↗

Oct 30, 2024device 510k652d agoGuangdong Genial Technology Co., Ltd. — Wearable Digital Thermometer (T31) (510k cleared)

Product code: FLL. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗

Oct 30, 2024device 510k652d agoSmith & Nephew, Inc. — JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (510k cleared)SMITH & NEPHEW PLC

Product code: HSX. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Oct 30, 2024device 510k652d agoIzenimplant Co., Ltd. — ZENEX Implant System_Long (510k cleared)

Product code: DZE. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Oct 30, 2024device 510k652d agoHistoSonics, Inc. — Edison System (510k cleared)

Product code: QGM. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

Oct 30, 2024device 510k652d agoNingbo Medsun Medical Co., Ltd. — Safety Lancet (510k cleared)

Product code: FMK. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

Oct 30, 2024device 510k652d agoTaiwan Main Orthopaedic Biotechnology Co., Ltd. — Caduceus S (510k cleared)

Product code: SBF. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Oct 30, 2024device 510k652d agoLagis Enterprise Co., Ltd. — LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) (510k cleared)Cre8 Enterprise Ltd

Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗

Oct 31, 2024approval651d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: STRIDES PHARMA. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Oct 31, 2024approval651d agoNICARDIPINE HYDROCHLORIDE — FDA approvalNICARDIPINE HYDROCHLORIDE

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

full page →NICARDIPINE HYDROCHLORIDE →fda approvals ↗

Oct 31, 2024approval651d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: UNICHEM. Form: TABLET. Route: ORAL

Week of Oct 28, 2024