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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,728 grant · 4,686 phase readout · 2,347 8k filing · 2,000 device pma

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2026-07-20: 0 catalysts2026-07-21: 0 catalysts2026-07-22: 14 catalysts2026-07-23: 2 catalysts2026-07-24: 1 catalyst2026-07-25: 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: 0 catalysts2026-09-02: 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
  • grant4,728
  • phase readout4,686
  • 8k filing2,347
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings292
  • therapy area

    no tagged catalysts yet

    Week of Oct 7, 2024

    50
    ›Oct 8, 2024device 510k653d agoTheranica Bio-Electronics, Ltd. — Nerivio; NerivioInfinity (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k653d agoZheJiang Decans Medical Devices Co., Ltd. — Gemini Medical Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k653d agoSichuan Qianii-Beoka Medical Technoiogy Lnc. — Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k653d agoHunan Vathin Medical Instrument Co., Ltd. — Single-use Ureteral Access Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k653d agoOmron Healthcare, Inc. — Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) (510k cleared)HCA Healthcare, Inc.

    Product code: QXY. Advisory committee: Cardiovascular. Type: Direct

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k653d agoSejoy Biomedical Co., Ltd. — Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System (510k cleared)ACRO BIOMEDICAL CO., LTD.

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k653d agoLucens Technology Co., Ltd. — Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens (510k cleared)Lens Technology Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k653d agoChurch & Dwight Co., Inc. — TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (510k cleared)CHURCH & DWIGHT CO INC /DE/

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k653d agoLife Spine, Inc. — ProLift Wedge Expandable Spacer System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k653d agoMeta Biomed Co., Ltd. — Jet Flow Bulk (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k653d agoZheJiang J&J Mobility Co., Ltd. — Power Wheelchair (JJW-6001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k652d agoTruabutment, Inc. — TruAbutment DS; TruBase (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k652d agoWeero Co., Ltd. — eMVFit (MVF-10M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k652d agoShanghai Care US Medical Product Co., Ltd. — CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k652d agoCarlsmed, Inc. — aprevo® anterior lumbar interbody fusion device with interfixation (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k652d agoSu-Ko Technologies, LLC — SER Pen Carain MicroSystem (MP1209SP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k652d agoH.S Hospital Service S.P.A — TRAP EASY (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k652d agoThermo Fisher Scientific — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k652d agoOsteoCentric Technologies — OsteoCentric Technologies Cannulated Fasteners and Nuts (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k652d agoAuxein Medical Pvt., Ltd. — Clavicle and Scapula System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k652d agoLimbus Ai, Inc. — Limbus Contour (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k652d agoMedicreations, LLC — MEDIYAG (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoGreens Surgicals Pvt. , Ltd. — GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoEpic Medical Pte. , Ltd. — ProSeal™ In Line Pump Set (423850) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoBausch & Lomb, Incorporated — EyeGility™ Inserter for Preloaded enVista IOLs (510k cleared)Bausch & Lomb Corp

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoHeartLung Corporation — AutoChamber (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoYilink (Tianjin) Biotechnology Co., Ltd. — Dental porcelain powder (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoSiemens Healthcare Diagnostics Products GmbH — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (510k cleared)Taho Pharmaceuticals Ltd

    Product code: QLU. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoCtl Medical Corporation — KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoIcardio.Ai — EchoMeasure (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoB.T.I. Biotechnology Institute, Sl. — BTI Interna 3.0 Dental Implant System UnicCa® (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoBLUECORE COMPANY Co., Ltd. — Lasya-Trinity (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoStryker Corporation (Tornier, S.A.S.) — Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoShanghai United Imaging Healthcare Co., Ltd. — uDR 380i Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoQuanta System Spa — Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoWeero Co., Ltd. — eMVFit (MVF-10M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k651d agoAmbu A/S — Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoBeckman Coulter, Inc. — Access Toxo IgM II (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoOrmco Corporation — Spark™ Clear Aligner System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoAiros Medical, Inc. — ARTAIRA Arterial Compression Device (AACD01) (510k cleared)AVANOS MEDICAL, INC.

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoQx World, Ltd. — QUEX ED; QUEX S (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoAnhui Deepblue Medical Technology Co., Ltd. — HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoProgressive Aligners, Inc. — Progressive Orthodontics App (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoAccure Acne, Inc. — Accure Laser System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoSterilmed, Inc. — Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoDongguan Tutamen Metalwork Co., Ltd. — PBM Hair Therapy Cap (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoJdentalcare Srl — JDZygoma dental implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoCopan Italia Spa — UriSponge™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoFujifilm Corporation — Hood (DH-083ST) (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoHeidelberg Engineering GmbH — SPECTRALIS with Flex Module (510k cleared)

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

    full page →fda device 510k ↗
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    $ACBM
    $HCA373.09+0.72%
    $CARL
    $BLCO15.990.00%
    $CHD96.91+1.21%
    $LNTCY
    $TMO447.81+1.31%
    $AVNS