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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma

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2026-07-20: 0 catalysts2026-07-21: 0 catalysts2026-07-22: 0 catalysts2026-07-23: 0 catalysts2026-07-24: 29 catalysts2026-07-25: 0 catalysts2026-07-26: 0 catalysts2026-07-27: 2 catalysts2026-07-28: 4 catalysts2026-07-29: 12 catalysts2026-07-30: 12 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 12 catalysts2026-08-05: 14 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 1 catalyst2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 0 catalysts2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 0 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: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 0 catalysts2026-09-04: 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: 0 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: 0 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,415
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Dec 16, 2024

    50
    ›Dec 17, 2024device 510k585d agoVentana Medical Systems, Inc. — Roche Digital Pathology Dx (510k cleared)MERIT MEDICAL SYSTEMS INC

    Product code: PSY. Advisory committee: Pathology. Type: Special

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoDentsply Sirona, Inc. — Lucitone Digital Print Denture™ System (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoAllengers Global Healthcare Private Limited — Thulium Fiber Laser (FiberLAZE+, FiberLAZE) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoCntrl+, Inc. — Cntrl+ Bladder Support Pessary (510k cleared)

    Product code: HHW. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoAllonus Tech Co., Ltd. — ALLONUS Tech Prosthetics (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoCentinel Spine, LLC — prodisc® L Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoCepheid® — Xpert MRSA/SA SSTI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoLima Corporate S.P.A. — Physica Porous Femoral Components (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoArtsmedia Denmark Aps — ARTSMedia Semen Wash Medium (510k cleared)

    Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoArtsmedia Denmark Aps — ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) (510k cleared)

    Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoNatec Medical , Ltd. — Amethyst HP PTA OTW 0.035 Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoSOADCO, S.L. — Klockner Kits (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoChongqing Moffy Innovation Technology Co., Ltd. — Respiratory Muscle Trainer (510k cleared)Hang Feng Technology Innovation Co., Ltd.

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoViasonix , Ltd. — Falcon/Xpress (Falcon/Xpress) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoCadwell Industries, Inc. — Bluebird Single-Use Respiratory Effort Belt (510k cleared)POWELL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoChangsha Anxiang Medical Technology Co., Ltd. — Tens & Ems Device (TU1080) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoDeltamed GmbH — 3Delta UNlimited (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoTeknimed Sas — GENTAFIX® (1, 3, 3MV) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoHunan Vathin Medical Instrument Co., Ltd. — Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoVentris Medical — Porous Biologic Scaffold (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoCaerus Corporation — Active System; Avenue8 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoQuest Medical, Inc. — Lyka® PORT Needle Free Access Device (4170Y) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoEtex Corporation — EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k584d agoFreudenberg Medical, LLC — FirstFit Surgical Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoCardinalhealth — Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) (510k cleared)CARDINAL HEALTH INC

    Product code: PNR. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoWassenburg Medical, Inc. — System 83 Revolve Endoscope Washer/Disinfector (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoVygon USA — Nutrifit (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoYongkang Hengyi Vehicle Co., Ltd. — Electric Wheelchair (HC820N) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoStryker Neurovascular — Broadway 8 Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoJoytech Healthcare Co. , Ltd. — Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) (510k cleared)NVP Healthcare Co Ltd

    Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoOrthofix Srl — OrthoNext Platform System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoInnocare Optoelectronics Corp. — Yushan X-Ray Flat Panel Detector (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoCollagen Matrix, Inc. — Bovine Dermis Collagen Dermal Matrix (510k cleared)

    Product code: KGN. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoCristaline Aligners GmbH — Cristaline Aligners Z FLX (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoDeepHealth, Inc. — Saige-Density (2.5.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoMedline Industries, LP — Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoBecton, Dickinson and Company — BD Vaginal Panel (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoDeepHealth, Inc. — Saige-Dx (3.1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoQuickdent Devices Private , Ltd. — Quickdent Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoShanghai Sigma High-Tech Co., Ltd. — UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoSynchrony Medical , Ltd. — LibAirty Airway Clearance System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoStryker Neurovascular — Echo Intracranial Base Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d 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: NFO. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoShenzhen Nuon Medical Equipment Co., Ltd. — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoImplant Protesis Dental 2004, S.L. — IPD Dental Implant Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoOnward Medical, Inc. — ARC-EX System (510k cleared)Picard Medical, Inc.

    Product code: SDO. Advisory committee: Physical Medicine. Type: Direct

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoMedline Industries, LP — Hudson RCI Comfort Flo® CubCannula™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoImbio, Inc. — IQ-UIP (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k583d agoDmc Importacao E Exportacao DE Equipamentos Ltda — Therapy EC, Therapy XT (510k cleared)

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

    full page →fda device 510k ↗
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    page 16 of 100
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    $MMSI74.32+1.66%
    $POWL
    $FOFO3.0000+2.39%
    $FRTRY
    $BDX156.36+2.22%
    $CAH228.03+0.91%
    $XRAY12.93+1.61%
    $TMO447.81+1.31%
    $PMI0.1821-4.66%