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calendar

23,815 catalysts · 5,000 device 510k · 4,728 grant · 3,928 approval · 3,368 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-17: 19 catalysts2026-08-18: 2 catalysts2026-08-19: 3 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: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts
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  • device 510k5,000
  • grant4,728
  • approval3,928
  • 8k filing3,368
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Oct 21, 2024

    31
    ›Oct 24, 2024device 510k663d agoImplantcast GmbH — MUTARS® femoral stem cemented 160 mm and 200 mm (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k663d agoArgen Corporation — ArgenZ MTZ (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k663d agoKeystone Industries — KeyPrint KeyDenture Base (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k663d agoShenzhen Urion Technology Co., Ltd. — Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k663d agoFoshan Shunkangda Medical Tech Co., Ltd. — Manual Wheelchair (SYIV100-CA9221) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k663d agoPhilips Medical Systems Nederland B.V. — ROCC Console (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024approval662d agoNOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approvalPOSACONAZOLE

    Sponsor: MSD MERCK CO. Form: FOR SUSPENSION, DELAYED RELEASE. Route: ORAL

    full page →POSACONAZOLE →fda approvals ↗
    ›Oct 25, 2024approval662d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

    Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

    full page →POSACONAZOLE →fda approvals ↗
    ›Oct 25, 2024approval662d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

    Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Oct 25, 2024approval662d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

    Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →POSACONAZOLE →fda approvals ↗
    ›Oct 25, 2024approval662d agoORLYNVAH (PROBENECID) — FDA approvalLannett Co Inc

    Sponsor: ITERUM THERAP. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 25, 2024device 510k662d agoSimBioSys, Inc. — TumorSight Viz (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoShenzhen Beacon Display Technology Co., Ltd. — LCD Monitors C310S, G310S, C316S, G316S, C616W (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoShenzhen Yimi Life Technology Co., Ltd. — Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoNorlase Aps — LYNX Photocoagulator (510k cleared)

    Product code: HQF. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoAvanos Medical, Inc. — CORGRIP* SR NG/NI Tube Retention System (510k cleared)AVANOS MEDICAL, INC.

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoMetko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi — FMT Disposable and Autoclavable Temperature Probes (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoNeurophet., Inc. — Neurophet AQUA (V3.1) (510k cleared)NeurOp Inc

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoOrtho Development Corp. — BKS Revision System (510k cleared)DeFi Development Corp.

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoCryoconcepts LP — Freeze Point & Private Label Versions (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d ago3D Systems, Inc. — Cadence Ankle PSI System (510k cleared)3D SYSTEMS CORP

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoOcuject, LLC — LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoDistalmotion SA — Dexter L6 System (510k cleared)

    Product code: SDD. Advisory committee: General, Plastic Surgery. Type: Direct

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoBruno Vision Care, LLC — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism (510k cleared)

    Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoUlike Co., Ltd. — Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d ago3D Systems, Inc. — Salto Talaris Ankle PSI System (510k cleared)3D SYSTEMS CORP

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoBiotronik, Inc. — Pantera Pro; Pantera LEO (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoQIAGEN GmbH — QIAstat-Dx Respiratory Panel Mini (510k cleared)

    Product code: QOF. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoVATECH Co., Ltd. — VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoCepheid® — Xpert® SA Nasal Complete (510k cleared)

    Product code: NQX. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k662d agoComfort Rubber Gloves Industries Sdn. Bhd. — Nitrile Powder Free Examination Gloves Biodegradable (Green) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Oct 28, 2024

    19
    ›Oct 28, 2024approval659d agoPOTASSIUM CHLORIDE — FDA approvalTWi Pharmaceuticals Inc

    Sponsor: TWI PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 28, 2024device 510k
    ← prev
    page 15 of 477
    next →
    659d ago
    Medtronic Sofamor Danek USA, Inc. — Catalyft™ LS Expandable Interbody System (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Oct 28, 2024device 510k659d agoEthicon Endo-Surgery, LLC — ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2024device 510k659d agoNingbo Caremed Medical Products Co., Ltd. — Sterile Lancets for Single Use (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2024device 510k659d agoCuriteva, Inc. — Curiteva Porous PEEK Laminoplasty System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2024device 510k659d agoSpinal Alignment Solutions, Inc. — Spinal Alignment Solutions Pelvic Incidence (PI) Rod System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2024device 510k659d agoShenzhen Aozemei Technology Co., Ltd. — Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 28, 2024device 510k659d agoJellox Biotech, Inc. — MetaLite DX Digital Pathology Software (510k cleared)IO Biotech, Inc.

    Product code: QKQ. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 29, 2024approval658d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →asciminib hydrochloride →fda approvals ↗
    ›Oct 29, 2024approval658d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →asciminib hydrochloride →fda approvals ↗
    ›Oct 29, 2024approval658d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

    Sponsor: DR REDDYS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 29, 2024device 510k658d agoMicro Therapeutics, Inc. d/b/a ev3 Neurovascular — Riptide Aspiration System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k658d agoHunan Vathin Medical Instrument Co., Ltd. — Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) (510k cleared)

    Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k658d agoDehas Medical Systems GmbH — QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k658d agoDevicor Medical Products, Inc. — Mammotome AutoCore™ Single Insertion Core Biopsy System (510k cleared)UTAH MEDICAL PRODUCTS INC

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

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k658d agoAtriCure, Inc. — AtriCure cryoICE BOX (ACM) (510k cleared)AtriCure, Inc.

    Product code: GXH. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k658d agoRiverpoint Medical — OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k658d agoQIAGEN GmbH — QIAstat-Dx Meningitis/Encephalitis (ME) Panel (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k658d agoTigon Medical — Tigon Medical Fractures, Instability, and Reconstruction (FIRE) (510k cleared)

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

    full page →fda device 510k ↗
    $DDD
    $DDD
    $DFUKF
    $FRTRY
    $AVNS
    $FRTRY
    $MRK135.84+0.21%
    $FRTRY
    $NVS150.88-0.55%
    $UTMD69.19+0.06%
    $NVS150.88-0.55%
    $ATRC
    $IOBTQ