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calendar

12 catalysts · 11 device 510k · 1 approval

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  • device 510k11
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no tagged catalysts yet

Week of Feb 3, 2025

12
›Feb 3, 2025approval574d ago
VALPROIC ACID — FDA approvalCereno Scientific AB

Sponsor: CHARTWELL RX. Form: SYRUP. Route: ORAL

full page →fda approvals ↗
›Feb 3, 2025device 510k574d agoHuntleigh Healthcare , Ltd. — Sonicaid Team3 (510k cleared)

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

full page →fda device 510k ↗
›Feb 3, 2025device 510k574d agoMomentis Surgical , Ltd. — Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode (510k cleared)

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

full page →fda device 510k ↗
›Feb 3, 2025device 510k574d agoShenzhen Ulike Smart Electronics Co., Ltd. — JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) (510k cleared)

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

full page →fda device 510k ↗
›Feb 3, 2025device 510k574d agoGuangzhou Hehong Biotech Co., Ltd. — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) (510k cleared)Hangzhou DAC Biotech Co Ltd

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

full page →fda device 510k ↗
›Feb 3, 2025device 510k574d agoCytochip, Inc. — Cito CBC System (510k cleared)

Product code: GKZ. Advisory committee: Hematology. Type: Dual Track

full page →fda device 510k ↗
›Feb 3, 2025device 510k574d agoAlphatec Spine — IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer (510k cleared)

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

full page →fda device 510k ↗
›Feb 3, 2025device 510k574d agoMim Software, Inc. — Contour ProtégéAI+ (510k cleared)ASURE SOFTWARE INC

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

full page →fda device 510k ↗
›Feb 3, 2025device 510k574d agoPranaq Pte. , Ltd. — TipTraQ (TTQ001) (510k cleared)

Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗
›Feb 3, 2025device 510k574d agoZavation Medical Products, LLC — Tiger 2 System (510k cleared)

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

full page →fda device 510k ↗
›Feb 3, 2025device 510k574d agoGuangdong Xinyu Electronic and Technology Co., Ltd. — Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) (510k cleared)

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

full page →fda device 510k ↗
›Feb 3, 2025device 510k574d agoIhealth Labs, Inc. — iCare APP (510k cleared)

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

full page →fda device 510k ↗
$ASUR8.2700+1.35%