Calendar

Week of Feb 17, 2025

Feb 19, 2025device 510k540d agoSmith & Nephew — EVOS Pelvic and Acetabular System (510k cleared)SMITH & NEPHEW PLC

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

Feb 20, 2025device 510k539d agoGuangzhou Decheng Biotechnology Co., Ltd. — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (510k cleared)Guangzhou Zhiyi Biotechnology Co Ltd

Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoReveal Lasers , Ltd. — Medical diode laser systems (CHARISMA, REGAL) (510k cleared)

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

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoSteris Corparation — Defendo Fujifilm 700 Single Use Cleaning Adapter (510k cleared)

Product code: ODC. Advisory committee: Gastroenterology, Urology. Type: Special

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoArthrex, Inc. — Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures (510k cleared)

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

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoCaristo Diagnostics , Ltd. — CaRi-Plaque (510k cleared)

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

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoUnimed Medical Supplies, Inc. — Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91) (510k cleared)

Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoIpreg Incorporation — SperSort Sperm Sorting Chip (IPG02) (510k cleared)

Product code: MQK. Advisory committee: Obstetrics/Gynecology. Type: Traditional

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoEver Fortune.Ai, Co., Ltd. — EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) (510k cleared)

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

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoOrmco Corporation — SparkTM Clear Aligner System (510k cleared)

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

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoSteritec Products, Inc. (A Getinge Company) — Green Card Bowie-Dick Test (BD115) (510k cleared)

Product code: JOJ. Advisory committee: General Hospital. Type: Special

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoNurodata, Inc. — NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) (510k cleared)

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

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoCardiocalm Srl — CER-S (510k cleared)

Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoLinkBio Corp. — CORE Shoulder System (510k cleared)

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

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoCompumedics Limited — Falcon HST (510k cleared)

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

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoEdan Instruments, Inc. — Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) (510k cleared)VEECO INSTRUMENTS INC

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

full page →fda device 510k ↗

Feb 20, 2025device 510k539d agoAbbott Laboratories — Alinity h-series System (510k cleared)ABBOTT LABORATORIES

Product code: GKZ. Advisory committee: Hematology. Type: Traditional

full page →fda device 510k ↗

Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL

Week of Feb 17, 2025