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calendar

22 catalysts · 20 device 510k · 2 approval

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no tagged catalysts yet

Week of Nov 25, 2024

22
›Nov 26, 2024approval643d ago
CHILDREN'S ZYRTEC HIVES (CETIRIZINE HYDROCHLORIDE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗
›Nov 26, 2024approval643d agoRALDESY (TRAZODONE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KAMAT. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗
›Nov 26, 2024device 510k643d agoLVIS Corporation — NeuroMatch (510k cleared)

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoTraferox Technologies, Inc. — LungProtect (510k cleared)TETRA TECHNOLOGIES INC

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoCirca Scientific, Inc. — Cross Wise™ Multi-Use RF Adapter Cable (510k cleared)Clear Scientific Inc

Product code: DXF. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoAtlas Spine, Inc. — Atlas Spine Lateral Expandable Interbody System (510k cleared)

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoVarian Medical Systems — Intraluminal Applicator Set (510k cleared)

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoDentscare Ltda — PrimmaArt (510k cleared)

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoRadunity Corp. — RadUnity (Version 1.0.0) (510k cleared)

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoColoplast Corp. — SureCath Set (510k cleared)

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoVIOL Co., Ltd. — Cellinew (510k cleared)

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoSmith & Nephew Inc., Endoscopy Div. — REGENETEN™ Bioinductive Implant (510k cleared)SMITH & NEPHEW PLC

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoTriMed, Inc. — TriMed Posterior Malleolus Fixation System (510k cleared)

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoTerumo Corporation — R2P Radifocus Glidewire Advantage (510k cleared)

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoSolco Biomedical Co., Ltd. — 4CIS® Chiron Spinal Fixation System (510k cleared)ACRO BIOMEDICAL CO., LTD.

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoRiverpoint Medical, LLC — OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct (510k cleared)

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

Product code: JWY. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoSprintray, Inc. — Digital Temp (510k cleared)

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoShenzhen Imdk Medical Technology Co., Ltd. — Arm Blood Pressure Monitor (model: BPM-A7VL) (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoAsg Superconductors S.P.A. — MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) (510k cleared)

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

full page →fda device 510k ↗
›Nov 26, 2024device 510k643d agoFootbridge Medical — HyperFlex™ Bunion Correction System (510k cleared)

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

full page →fda device 510k ↗
$KVUE19.17-0.16%
$TMO447.81+1.31%
$TTI
$ISRG372.60+1.51%
$ACBM
$SNN28.97-0.55%