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5,000 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 0 catalysts2026-07-29: 0 catalysts2026-07-30: 0 catalysts2026-07-31: 0 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 17 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 2 catalysts2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 1 catalyst2026-08-14: 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 catalysts2026-10-19: 0 catalysts2026-10-20: 1 catalyst2026-10-21: 1 catalyst2026-10-22: 2 catalysts2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,347
  • device 510k5,000
  • grant4,728
  • 8k filing2,603
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Sep 15, 2025

    19
    ›Sep 19, 2025device 510k317d agoMedica USA, Inc. — Purema H Hemoconcentrator - Pediatric (510k cleared)Medunik USA Inc

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoShanghai United Imaging Healthcare Co., Ltd. — uDR Aurora CX (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoTempus AI, Inc. — xR IVD (510k cleared)Tempus AI, Inc.

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoOptmed, Inc. — BondEase 2 Topical Skin Adhesive (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoOlympus Medical Systems Corp. — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoIpg Medical Corporation — IPGTFL-02 (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoHuntleigh Healthcare , Ltd. — Sonicaid Team3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoNakanishi, Inc. — UniBur (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoAnhui Happiness Workshop Medical Instruments Co., Ltd. — Single Use Suction-Evacuation Ureteral Access Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoVideahealth, Inc. — Videa Dental AI (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoShenzhen Jermei Medical Device Technology Co., Ltd. — Portable mesh nebulizer (JM821) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoEmbody, Inc. — Tapestry Biointegrative Implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoGC America, Inc. — EQUIA LC ONE (510k cleared)PARKS AMERICA, INC

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoVericom Co., Ltd. — Well-Root PT (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoNvision Biomedical Technologies, Inc. — Impact PEEK Union Nail System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoUnibeauty (Hubei) Technology Co., Ltd. — Unscented menstrual three-piece applicator tampon (510k cleared)

    Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Special

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoNakanishi, Inc. — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoZeus Scientific — Alegria Flash ENA Screen (510k cleared)Dawn Sea Therapeutics

    Product code: LLL. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoCytocell Limited — KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) (510k cleared)

    Product code: SFS. Advisory committee: Hematology. Type: Direct

    full page →fda device 510k ↗

    Week of Sep 22, 2025

    31
    ›Sep 22, 2025device 510k314d agoSurgical Principals, Inc. — SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 22, 2025device 510k
    ← prev
    page 65 of 100
    next →
    314d ago
    Karl Storz SE & CO. KG — ENDOFLATOR + (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 22, 2025device 510k314d agoJinan Babio Biotechnology Co., Ltd. — Babio® Virus Transport Kit (Non-inactivating) (510k cleared)Cellyan Biotechnology Co., Ltd

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

    full page →fda device 510k ↗
    ›Sep 22, 2025device 510k314d agoAngioSafe, Inc. — Santreva™-ATK Endovascular Revasculariztion Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 22, 2025device 510k314d agoDiagnostic Green GmbH — IC-Flow™ Imaging System 2.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 23, 2025device 510k313d agoHangzhou SHINING3D Dental Technology Co., Ltd. — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 23, 2025device 510k313d agoOlympus Winter & Ibe GmbH — Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 23, 2025device 510k313d agoCanyon Medical, Inc. — Polyvinyl Alcohol Embolic Microspheres (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 23, 2025device 510k313d agoBiolinq Incorporated — Biolinq Shine Autonomous Time-in-Range Microsensor (510k cleared)

    Product code: SFU. Advisory committee: Clinical Chemistry. Type: Direct

    full page →fda device 510k ↗
    ›Sep 23, 2025device 510k313d agoHimaging Technology (Shanghai) Co., Ltd. — Himaging Bronchscope System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 23, 2025device 510k313d agoIschemaview, Inc. — Rapid Aortic Measurements (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 23, 2025device 510k313d agoIntuitive Surgical, Inc. — Ion Endoluminal System (IF1000) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Sep 23, 2025device 510k313d agoZenflow, Inc. — Zenflow Spring Scope (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 23, 2025device 510k313d agoLuminance Medical Ventures, Inc. — Luminance Red Cold Sore Device (TN1927G) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 23, 2025device 510k313d agoEdwards Lifesciences, LLC — Edwards MC3 Tricuspid annuloplasty ring (4900) (510k cleared)Edwards Lifesciences Corp

    Product code: KRH. Advisory committee: Cardiovascular. Type: Abbreviated

    full page →fda device 510k ↗
    ›Sep 23, 2025device 510k313d agoAirs Medical, Inc. — SwiftSight-Brain (510k cleared)AVITA Medical, Inc.

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

    full page →fda device 510k ↗
    ›Sep 23, 2025device 510k313d agoM/s. Meril Endo Surgery Private Limited. — PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 24, 2025device 510k312d agoSTERIS Corporation — Celerity™ 20 HP Biological Indicator (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›Sep 24, 2025device 510k312d agoShanghai United Imaging Healthcare Co., Ltd. — uWS-Angio Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 24, 2025device 510k312d agoResitu Medical AB — Resitu Slider 09 (RESL09) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 24, 2025device 510k312d agoBoston Scientific Corporation — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Sep 24, 2025device 510k312d agoAlcon Laboratories, Inc. — LenSx Laser System (8065000944) (510k cleared)Alcon Laboratories Inc

    Product code: OOE. Advisory committee: Ophthalmic. Type: Special

    full page →fda device 510k ↗
    ›Sep 24, 2025device 510k312d agoDentimax, Inc. — Digital X-Ray DentiMax Pro Imaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 24, 2025device 510k312d agoAlma Lasers, Inc. — Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 24, 2025device 510k312d agoTandem Diabetes Care, Inc. — t:slim X2 insulin pump with interoperable technology (510k cleared)TANDEM DIABETES CARE INC

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

    full page →fda device 510k ↗
    ›Sep 24, 2025device 510k312d agoProverum Limited — ProVee Video Processing Unit (PV-003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 24, 2025device 510k312d agoKulzer, LLC — Retraxil (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 24, 2025device 510k312d agoImaxeon Pty, Ltd. — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 24, 2025device 510k312d agoSurmodics,Inc. — Pounce(TM) Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 24, 2025device 510k312d agoEndorobotics Co., Ltd. — ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoBistos Co., Ltd. — Hi bebe super (BT-150B) (510k cleared)

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

    full page →fda device 510k ↗
    $PRKA
    $TEM
    $ISRG353.33+0.10%
    $RCEL4.4000-2.00%
    $HKPD
    $EW91.33-2.47%
    $TNDM19.50+2.58%
    $BSX46.73+1.59%
    $STE228.40-1.22%