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calendar

18 catalysts · 16 device 510k · 2 approval

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no tagged catalysts yet

Week of May 12, 2025

18
›May 15, 2025approval473d ago
SPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

full page →fda approvals ↗
›May 15, 2025approval473d agoZYNYZ (RETIFANLIMAB-DLWR) — FDA approvalretifanlimab

Sponsor: INCYTE CORP. Form: INJECTABLE. Route: INTRAVENOUS

full page →retifanlimab →fda approvals ↗
›May 15, 2025device 510k473d agoNIKKISO CO., LTD. — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (510k cleared)

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

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoStryker Instruments — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) (510k cleared)

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

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoC.R. Bard, Inc. — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) (510k cleared)

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

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoNeuraxis — NeurAxis IB-Stim (01-1020) (510k cleared)Neuraxis, INC

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

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoWe Medical Technology (Wuxi) Co., Ltd. — Youmagic FLM System (YM5-U1) (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoEdwards Lifesciences, LLC — Hypertension Prediction Index (HePI) Algorithm (510k cleared)Edwards Lifesciences Corp

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

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoGuard Medical, Inc. — NPseal (510k cleared)Picard Medical, Inc.

Product code: OKO. Advisory committee: General, Plastic Surgery. Type: Special

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoEywa Srl — Limfa Therapy System (Limfa Therapy) (510k cleared)

Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoOlympus Medical Systems Corporation — Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) (510k cleared)

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

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoNIKKISO CO., LTD. — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) (510k cleared)

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

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoNIKKISO CO., LTD. — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU (510k cleared)

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

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoEmbolization, Inc. — Nitinol Enhanced Device (NED) (510k cleared)

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

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoMekics Co., Ltd. — HFT750U (510k cleared)

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

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoHardy Diagnostics — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) (510k cleared)Bristol-Myers Squibb Co

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

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoPhilips Ultrasound — Lumify Diagnostic Ultrasound System (510k cleared)Ocuvex Therapeutics Inc

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

full page →fda device 510k ↗
›May 15, 2025device 510k473d agoMicroport Orthopedics, Inc. — NEXUS® Hip Stem (510k cleared)

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

full page →fda device 510k ↗
$EW91.33-2.47%
$PMI0.1821-4.66%
$NRXS
$INCY124.37-2.64%