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calendar

30 catalysts · 24 device 510k · 6 approval

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2026-08-10: 65 catalysts2026-08-11: 16 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 20 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 8 catalysts2026-11-03: 16 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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Week of Mar 31, 2025

30
›Apr 4, 2025approval494d ago
SIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

full page →tedizolid phosphate →fda approvals ↗
›Apr 4, 2025approval494d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

full page →tedizolid phosphate →fda approvals ↗
›Apr 4, 2025approval494d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL

full page →AMBRISENTAN →fda approvals ↗
›Apr 4, 2025approval494d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: SIGMAPHARM LABS LLC. Form: TABLET. Route: ORAL

full page →AMBRISENTAN →fda approvals ↗
›Apr 4, 2025approval494d agoAMBRISENTAN — FDA approvalSigmapharm Laboratories LLC

Sponsor: SUN PHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Apr 4, 2025approval494d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →AMBRISENTAN →fda approvals ↗
›Apr 4, 2025device 510k494d agoBiotronik, Inc. — Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoNingbo Dechang Electrical Machinery Made Co.,Ltd — LED Light Therapy Mask (RT01) (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoPhilips Medical Systems Nederland B.V. — Philips VSC-MEDlib (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoABBOTT MEDICAL — JETi Hydrodynamic Thrombectomy System (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoDeski — HeartFocus (V.1.1.1) (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoTerumo Europe N.V. — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoHighridge Medical, LLC — Virage® OCT Spinal Fixation System (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoWuhan Pioon Technology Co., Ltd. — Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoTurbett Surgical — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Viral Transport Medium (510k cleared)Hangzhou DAC Biotech Co Ltd

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoPrapela, Inc. — Prapela SVS hospital bassinet pad (model P01) (510k cleared)

Product code: QVY. Advisory committee: General Hospital. Type: Direct

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoApex BioTechnology Corp. — UASure II Blood Uric Acid Monitoring System (510k cleared)PDS Biotechnology Corp

Product code: PTC. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoDraegerwerk AG & CO Kgaa — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoRaySearch Laboratories AB (PUBL) — RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup (510k cleared)Hangzhou DAC Biotech Co Ltd

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoWhoop., Inc. — WHOOP ECG (electrocardiogram) Feature (1.0) (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoSpectrum Spine, Inc. — Spectrum Spine Lumbar Cage System (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoFoqus Technologies, Inc. — DeepFoqus (DeepFoqus-Accelerate) (510k cleared)FOXO TECHNOLOGIES INC.

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoDegen Medical — DeGen Medical Patient Specific Implant (PSI) System (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoFresenius Medical Care Renal Therapies Group, LLC — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) (510k cleared)Fresenius Medical Care AG

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d ago3Shape TRIOS A/S — TRIOS Ready Tip (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoOculogica, Inc. — EyeBOX EBX-4.1 (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoQfr Solutions BV — QFR (3.0) (510k cleared)

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

full page →fda device 510k ↗
›Apr 4, 2025device 510k494d agoSeigla Medical, Inc. — LiquID .051 LP Guide Catheter Extension (510k cleared)

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

full page →fda device 510k ↗
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$FMS24.36+0.37%
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