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23,077 catalysts · 4,900 device 510k · 4,728 grant · 3,532 approval · 3,126 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 97 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: 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 catalysts
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type
  • device 510k4,900
  • grant4,728
  • approval3,532
  • 8k filing3,126
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Oct 21, 2024

    35
    ›Oct 24, 2024device 510k657d agoMedtronic Neurosurgery — Duet External Drainage and Monitoring System (EDMS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k657d agoGt Metabolic Solutions, Inc. — MagDI System (MAG-01, DS-01) (510k cleared)Seed Health Inc

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k657d agoMedency S.R.L. — Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k657d agoDentsply Sirona — CEREC Cercon 4D CAD/CAM Blocks (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k657d 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 510k657d agoArgen Corporation — ArgenZ MTZ (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k657d agoKeystone Industries — KeyPrint KeyDenture Base (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k657d 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 510k657d 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 510k657d 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, 2024approval656d agoNOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

    full page →POSACONAZOLE →fda approvals ↗
    ›Oct 25, 2024approval656d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

    full page →POSACONAZOLE →fda approvals ↗
    ›Oct 25, 2024approval656d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

    Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Oct 25, 2024approval656d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

    full page →POSACONAZOLE →fda approvals ↗
    ›Oct 25, 2024approval656d agoORLYNVAH (PROBENECID) — FDA approvalLannett Co Inc

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

    full page →fda approvals ↗
    ›Oct 25, 2024device 510k656d agoSimBioSys, Inc. — TumorSight Viz (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k656d 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 510k656d 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 510k656d agoNorlase Aps — LYNX Photocoagulator (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k656d 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 510k656d 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 510k656d 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 510k656d 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 510k656d 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 510k656d 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 510k656d 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 510k656d 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 510k656d 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 510k656d 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 510k656d 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 510k656d agoBiotronik, Inc. — Pantera Pro; Pantera LEO (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k656d 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 510k656d 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 510k656d agoCepheid® — Xpert® SA Nasal Complete (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k656d 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

    15
    ›Oct 28, 2024approval653d 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 5 of 462
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    653d 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 510k653d 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 510k653d 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 510k653d 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 510k653d 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 510k653d 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 510k653d 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, 2024approval652d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →asciminib hydrochloride →fda approvals ↗
    ›Oct 29, 2024approval652d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →asciminib hydrochloride →fda approvals ↗
    ›Oct 29, 2024approval652d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

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

    full page →fda approvals ↗
    ›Oct 29, 2024device 510k652d 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 510k652d 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 510k652d 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 510k652d 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 ↗
    $MRK130.88-0.03%
    $AVNS
    $FRTRY
    $XRAY11.61-0.43%
    $DFUKF
    $FRTRY
    $DDD
    $FRTRY
    $IOBTQ
    $DDD
    $NVS155.21-1.01%
    $NVS155.21-1.01%
    $UTMD69.19+0.06%