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23,037 catalysts · 4,900 device 510k · 4,728 grant · 3,532 approval · 3,086 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 57 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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  • device 510k4,900
  • grant4,728
  • approval3,532
  • 8k filing3,086
  • 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 14, 2024

    5
    ›Oct 18, 2024device 510k663d agoRestor3D — Kinos Total Ankle System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k663d agoMvision AI OY — Contour+ (MVision AI Segmentation) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k663d agoColoplast Corp. — Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k663d agoXiantao Daoqi Plastic Co., Ltd. — Surgical Face Mask (Tie on/ Ear loops) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k663d agoOystershell NV — Pixie Skin Tag (510k cleared)

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

    full page →fda device 510k ↗

    Week of Oct 21, 2024

    45
    ›Oct 21, 2024approval660d agoORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — FDA approvalberotralstat hydrochloride

    Sponsor: BIOCRYST. Form: CAPSULE. Route: ORAL

    full page →berotralstat hydrochloride →fda approvals ↗
    ›Oct 21, 2024device 510k
    ← prev
    page 4 of 461
    next →
    660d ago
    Stryker Instruments — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2024device 510k660d agoiRhythm Technologies, Inc. — Zio AT® device (A100A1001) (510k cleared)TTM TECHNOLOGIES INC

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

    full page →fda device 510k ↗
    ›Oct 21, 2024device 510k660d agoApple, Inc. — Digital Prism Correction Feature (DPCF) (510k cleared)Apple Inc.

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

    full page →fda device 510k ↗
    ›Oct 21, 2024device 510k660d agoMomentis Surgical , Ltd. — Anovo Surgical System (Model 6Ne) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2024device 510k660d agoTalladium España, SL — Dynamic TiBase; TRI Screws (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2024device 510k660d agoArthrex, Inc. — Arthrex VAL and VAL KreuLock™ Compression Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2024device 510k660d agoSmith & Nephew, Inc. — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Oct 21, 2024device 510k660d agoSpeciality Fibres and Materials, Ltd. — Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k659d agoBrosmed Medical Co., Ltd. — Tri-Wedge PTA Scoring Balloon Dilatation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k659d agoSiemens Medical Solutions USA, Inc. — ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k659d agoSol-Millennium Medical, Inc. — Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k659d agoAvita Corporation — Arm Type Blood Pressure Monitor (BPM82) (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k659d ago3-D Matrix Europe SAS — PuraStat (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k659d agoNordicneurolab AS — nordicMEDiVA (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k659d agoStryker Sustainability Solutions — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k659d agoShanghai SeeGen Photoelectric Technology Co., Ltd. — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k659d agoKarl Storz Endoscopy America, Inc. — KARL STORZ Holders (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k659d agoTianjin Mastervision Technology Co., Ltd. — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024approval658d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

    Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION

    full page →eculizumab biosimilar →fda approvals ↗
    ›Oct 23, 2024approval658d agoVIGABATRIN — FDA approvalVIGABATRIN

    Sponsor: ACCORD HLTHCARE. Form: FOR SOLUTION. Route: ORAL

    full page →VIGABATRIN →fda approvals ↗
    ›Oct 23, 2024approval658d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

    Sponsor: NOVITIUM PHARMA. Form: CAPSULE. Route: ORAL

    full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗
    ›Oct 23, 2024device 510k658d agoL&K BIOMED Co., Ltd. — BluEX Lumbar Expandable Cage System (510k cleared)NeuCen BioMed Co Ltd

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoMim Software, Inc. — MIM – Symphony HDR Fusion (510k cleared)ASURE SOFTWARE INC

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoEpic Medical Pte. , Ltd. — ProSeal™ Closed System Bag Access (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoVarian Medical Systems — Vitesse (5.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoGuangdong Optomedic Technologies, Inc. — FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoMedtronic Sofamor Danek USA, Inc. — CD Horizon™ Spinal System (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoAdaptiiv Medical Technologies, Inc. — TrueFit Bolus; TrueFlex Bolus (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoDRTECH Corporation — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoAffinity Biosensors, LLC — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoSpineart SA — Scarlet® AL-T (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoThe Orthopaedic Implant Company — OIC Small / Mini Fragment Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoScivita Medical Technology Co., Ltd. — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoParagonix Technologies — KIDNEYvault Portable Renal Perfusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoBiomet 3i, LLC — Immediate Molar Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoWeifang Mingliang Electronics Co., Ltd. — Fractional CO2 Laser Therapy System (EXFU CO2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoImmunodiagnostic Systems Limited — IDS-iSYS Free Testosterone (510k cleared)Transdermal Delivery Solutions Corp

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d agoTsk Laboratory International Japan KK — STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024approval657d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

    Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗
    ›Oct 24, 2024approval657d agoFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) — FDA approvalParatek Pharmaceuticals Inc

    Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗
    ›Oct 24, 2024approval657d agoHEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM) — FDA approvalHEPARIN SODIUM

    Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

    full page →HEPARIN SODIUM →fda approvals ↗
    ›Oct 24, 2024approval657d agoJUBBONTI (DENOSUMAB-BBDZ) — FDA approvalJUBBONTI

    Sponsor: SANDOZ INC. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →JUBBONTI →fda approvals ↗
    ›Oct 24, 2024approval657d agoHEPARIN SODIUM — FDA approvalHEPARIN SODIUM

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →HEPARIN SODIUM →fda approvals ↗
    ›Oct 24, 2024device 510k657d agoTelefield Medical Imaging (Shenzhen) Limited — Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) (510k cleared)

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

    full page →fda device 510k ↗
    $BCRX10.40+5.69%
    $AAPL298.01+0.70%
    $TTMI
    $AMGN414.03-0.76%
    $PFE26.63-1.57%
    $SNN30.11+0.12%
    $ASUR8.2700+1.35%
    $MDCE0.00020.00%