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19,683 catalysts · 4,728 grant · 3,153 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 46 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: 3 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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  • grant4,728
  • 8k filing3,153
  • device 510k2,768
  • approval2,721
  • device recall2,000
  • device pma1,955
device adverse event
1,000
  • recall693
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jun 23, 2025

    50
    ›Jun 26, 2025device 510k413d agoExactech, Inc. — Equinoxe® Scapula Fracture System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoOpen Implants, LLC — Sherlock (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoVioptix, Inc. — Lap.Ox™ Laparoscopic Tissue Oximeter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoTianjin Huahong Technology Co., Ltd. — safety lancet (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoAtmo Biosciences, Ltd. — Atmo Gas Capsule System (510k cleared)Brii Biosciences Ltd

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoGeistlich Pharma AG — SwissGraft X (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoTriMed, Inc. — TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoMedtronic Sofamor Danek USA, Inc. — The Rialto™ SI Fusion System (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoChengdu Daxan Innovative Medical Tech. Co., Ltd. — Disposable Intermittent Catheter (TPU Catheter) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025approval412d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

    Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jun 27, 2025approval412d agoSTELARA (USTEKINUMAB) — FDA approvalustekinumab

    Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

    full page →ustekinumab →fda approvals ↗
    ›Jun 27, 2025approval412d agoGAMIFANT (EMAPALUMAB-LZSG) — FDA approvalSobi Inc

    Sponsor: NOVIMMUNE S.A.. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jun 27, 2025approval412d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

    full page →PYZCHIVA →fda approvals ↗
    ›Jun 27, 2025approval412d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

    Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jun 27, 2025device pma412d agoMedtronic, Inc. — CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoAgilent Technologies, Inc. — PD-L1 IHC 22C3 PHARMDX (PMA supplement)AGILENT TECHNOLOGIES, INC.

    Supplement type: 30-Day Notice. Product code: PLS. Advisory committee: PA. Decision: OK30

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoMedtronic, Inc. — PulseSelect™ Pulsed Field Ablation (PFA) system (PMA supplement)Medtronic plc

    Supplement type: Normal 180 Day Track No User Fee. Product code: QZI. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoABBOTT MEDICAL — Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (PMA supplement)Postsurgical Therapeutics Inc

    Supplement type: Real-Time Process. Product code: NXW. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoMedtronic Cardiac Rhythm Disease Management — SelectSecure Lead (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoAgilent Technologies, Inc. — MAGE-A4 IHC 1F9 pharmDx (PMA supplement)AGILENT TECHNOLOGIES, INC.

    Supplement type: 30-Day Notice. Product code: SBL. Advisory committee: PA. Decision: OK30

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoShockwave Medical, Inc. — Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators (PMA supplement)

    Supplement type: Real-Time Process. Product code: QMG. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoAgilent Technologies, Inc. — PD-L1 IHC 28-8 pharmDx (PMA supplement)AGILENT TECHNOLOGIES, INC.

    Supplement type: 30-Day Notice. Advisory committee: PA. Decision: OK30

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoTempus Labs, Inc. — xT CDx (PMA supplement)Tempus AI, Inc.

    Supplement type: Real-Time Process. Product code: PQP. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Jun 27, 2025device 510k412d agoPhilips Medical Systems Nederland B.V. — Philips iCT CT system (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoUstomed Instrumente Ulrich Storz GmbH & Co. KG — USTOMED Bone Fixation/Bone Augmentation Systems - PIN (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoBecton Dickinson Infusion Therapy Systems, Inc. — BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoBiomet 3i, LLC — T3 Pro Implants– ZimVie Packaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoMoon Surgical — Maestro System (REF100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoDigital Surgery Systems, Inc. (D.B.A True Digital Surgery) — Affirm 800 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoSorin Group Italia S.R.L. — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoBoston Scientific Corporation — VIKING™ Fixed Curve Diagnostic Catheter (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoMulti4 Medical AB — Multi4 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoNeuromodulatory Devices & Applications — Ampa One System (AMPA-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoSpine Wave, Inc. — Testa TP Pivoting Spacer System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoColoplast Corp. — Luja Coudé (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoGuangdong Yadeng Medical Apparatus Co., Ltd., — Integral Dental Unit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoScopio Labs , Ltd. — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoGenostis AF — Genostis Osteosynthesis System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoCenterPoint Systems, LLC — CPS Locator 3D Plus Delivery Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoYian Medical Technology (Haining) Co., Ltd. — Dental CBCT X-ray System (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoEmpnia, Inc. — eMotus Respiratory Motion Management System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoRisu Medical Technology Co., Ltd. — Diode laser device (RF3120-BI) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoDent4you AG — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoRtm Vital Signs, LLC — RTMsense Respiratory Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoMicro-Tech (Nanjing) Co., Ltd. — Disposable Distal Cap (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoPAJUNK GmbH Medizintechnologie — SonoPlex STIM; SonoPlex II (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoCork Medical — Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (510k cleared)Medicale Corp.

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoCathegenix (Xiamen) Co., Ltd. — LumenaTM Ureteral Access Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoJeil Medical Corporation — FIX-C PEEK ACIF SA System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 29, 2025device 510k410d agoPendracare — Primum Hydrophilic Guiding Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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