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1,952 catalysts · 4,728 grant · 3,603 8k filing · 2,594 approval · 1,952 device 510k · 1,578 device recall · 1,359 device pma

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type: device 510k×from 2025-09-02×clear all
type
  • grant4,728
  • 8k filing3,603
  • approval2,594
  • device 510k1,952
  • device recall1,578
  • device pma1,359
device adverse event
1,000
  • earnings585
  • recall544
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Sep 1, 2025

    49
    ›Sep 2, 2025device 510k362d agoBelport Company, Inc., Gingi-Pak — RODIN Cement (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 2, 2025device 510k362d agoChengdu Besmile Medical Technology Co., Ltd. — Customized Abutment and Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 2, 2025device 510k362d agoAerogen, Ltd. — Aerogen Pro-X1 Controller System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 2, 2025device 510k362d agoPhilips Medizin Systeme Böblingen GmbH — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 2, 2025device 510k362d agoNaitive Technologies, Ltd. — OsteoSight™ Hip (v1) (510k cleared)TAT TECHNOLOGIES LTD

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

    full page →fda device 510k ↗
    ›Sep 2, 2025device 510k362d agoVelmeni, Inc. — VELMENI for DENTISTS (V4D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 2, 2025device 510k362d agoIgnite Orthomotion — Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoAlphatec Spine — IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoRestor3D — Kinos Total Ankle System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoMedicreations, LLC — MEDILIGHT (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoForest Devices, Inc. — SignalNED System (Model RE) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoA-1 Engineering — NeurotriS (SX2500); NeurotriS (SX3800) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoAvita Corporation — AViTA Arm Type Blood Pressure Monitor Cuff (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoDongguan E-Test Technology Co., Ltd. — Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoBlessing Cathay Corporation — AquaCast Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoBeijing Superlaser Technology Co., Ltd. — Diode laser therapy device (VADER) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoAgnes Medical Co., Ltd. — AGNES Ultra (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoArterys, Inc. — Tempus Pixel (510k cleared)Arteris, Inc.

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoPrismatik Dentalcraft, Inc. — BruxZir® NOW (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoCarestream Health, Inc. — Image Suite (510k cleared)HEALTHSTREAM INC

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoIschemaview, Inc. — Rapid Obstructive Hydrocephalus, Rapid OH (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoOptina Diagnostics, Inc. — Optina-4C (MHRC-C1N) (510k cleared)Co-Diagnostics, Inc.

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoCareverse Technology Pte. , Ltd. — Careverse CoronaryDoc (Careverse CoronaryDoc) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoBayer Medical Care, Inc. — Ball Joint Guide Array (66295) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoMicrobot Medical , Ltd. — LIBERTY Endovascular Robotic System (LIBERTYOS) (510k cleared)Microbot Medical Inc.

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoMicowey Medical Equipment (Guangxi) Co., Ltd. — Intense Pulsed Light Therapy Device (MMABM-1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoThe Surgical Company International BV (As Tsc Life) — Fluido® AirGuard System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoMag & More GmbH — Apollo TMS Therapy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoGuilin Woodpecker Medical Instrument Co., Ltd. — Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (510k cleared)

    Product code: EHD. Advisory committee: Dental. Type: Special

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoMedacta International S.A. — NextAR(TM) Shoulder Platform (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoMedtronic Sofamor Danek USA, Inc. — Endoskeleton™ Interbody Systems (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoMvision AI OY — Dose+ (1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoOniris — Oniris; Oniris Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoABBOTT MEDICAL — EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoClinical Laserthermia Systems, AB — Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoMedical Microinstruments, Inc. — Symani Surgical System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — KALA MINI 2.0 (KALA-04) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoItamar Medical , Ltd. — WatchPAT400 (WP400) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoZhejiang YiGao Medical Technology Co., Ltd. — Ureteral Access Sheath (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d ago3D-Shaper Medical S.L — 3D-SHAPER (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoGenabio Diagnostics, Inc. — GenaCheck COVID-19 Rapid Self-Test (510k cleared)Co-Diagnostics, Inc.

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoShandong Int Medical Instruments Co., Ltd. — High Pressure Tubing (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoPrytime Medical Devices, Inc. — pREBOA-PRO Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoIntravent Medical Partners — SOLOPASS 2.0 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoBard Access Systems, Inc. — Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoIntuitive Surgical, Inc. — Ion Endoluminal System (IF1000) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoThermo Fisher Scientific — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoSuturetech, Inc. — All-Suture Dual Anchor System (510k cleared)

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

    full page →fda device 510k ↗

    Week of Sep 8, 2025

    1
    ›Sep 8, 2025device 510k356d agoRev Neuro, LLC — DUO Microcatheter (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $TMO447.81+1.31%
    $MBOT
    $ISRG372.60+1.51%
    $CODX1.51000.00%
    $HSTM
    $CODX1.51000.00%
    $AIP
    $TATT