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calendar

32,574 catalysts · 18,765 approval · 4,865 device 510k · 3,955 grant · 2,000 device recall · 1,923 device pma · 1,066 recall

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2026-08-31: 0 catalysts2026-09-01: 0 catalysts2026-09-02: 0 catalysts2026-09-03: 13 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: 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: 1 catalyst2026-10-01: 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 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts2026-11-23: 0 catalysts2026-11-24: 0 catalysts2026-11-25: 0 catalysts2026-11-26: 0 catalysts2026-11-27: 0 catalysts2026-11-28: 0 catalysts2026-11-29: 0 catalysts
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  • approval18,765
  • device 510k4,865
  • grant3,955
  • device recall2,000
  • device pma1,923
  • recall1,066
  • earnings7
therapy area

no tagged catalysts yet

Week of Jun 23, 2025

24
›Jun 27, 2025device 510k434d 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 510k434d agoMoon Surgical — Maestro System (REF100) (510k cleared)

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

full page →fda device 510k ↗
›Jun 27, 2025device 510k434d 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 510k434d 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 510k434d 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 510k434d agoMulti4 Medical AB — Multi4 System (510k cleared)

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

full page →fda device 510k ↗
›Jun 27, 2025device 510k434d 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 510k434d 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 510k434d agoColoplast Corp. — Luja Coudé (510k cleared)

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

full page →fda device 510k ↗
›Jun 27, 2025device 510k434d 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 510k434d 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 510k434d agoGenostis AF — Genostis Osteosynthesis System (510k cleared)

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

full page →fda device 510k ↗
›Jun 27, 2025device 510k434d 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 510k434d 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 510k434d 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 510k434d 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 510k434d 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 510k434d 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 510k434d 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 510k434d 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 510k434d 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 510k434d 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 510k434d 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 510k432d agoPendracare — Primum Hydrophilic Guiding Catheter (510k cleared)

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

full page →fda device 510k ↗

Week of Jun 30, 2025

26
›Jun 30, 2025device pma431d agoPhysio-Control, Inc. — LIFEPAK FLEX™ Lithium-ion Battery (PMA supplement)

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

full page →fda device pma ↗
›Jun 30, 2025device pma
← prev
page 391 of 652
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431d ago
Baxter Healthcare Corp — FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (PMA supplement)Baxter Healthcare Corp

Supplement type: 30-Day Notice. Product code: PMX. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗
›Jun 30, 2025device pma431d agoNevro Corporation — Nevro Corp Senza Spinal Cord Stimulation (SCS) System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗
›Jun 30, 2025device pma431d agoTherakos Development Limited — THERAKOS® CELLEX® Photopheresis System Procedural Kit (PMA supplement)

Supplement type: 30-Day Notice. Product code: LNR. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗
›Jun 30, 2025device 510k431d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

full page →fda device 510k ↗
›Jun 30, 2025device 510k431d agoCarlsmed, Inc. — aprevo® posterior/transforaminal lumbar interbody fusion device (510k cleared)CARLSMED, INC.

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

full page →fda device 510k ↗
›Jun 30, 2025device 510k431d agoFUJIFILM Healthcare Americas Corporation — Synapse PACS (7.5) (510k cleared)

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

full page →fda device 510k ↗
›Jun 30, 2025device 510k431d agoVoluntis — HeroTracker Sense (510k cleared)

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

full page →fda device 510k ↗
›Jun 30, 2025device 510k431d agoMycardium AI Limited — EchoConfidence (USA) (510k cleared)

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

full page →fda device 510k ↗
›Jun 30, 2025device 510k431d agoShenzhen Chuangtong Yigou Technology Co., Ltd. — Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) (510k cleared)

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

full page →fda device 510k ↗
›Jun 30, 2025device 510k431d agoPiur Imaging GmbH — PIUR tUS inside (510k cleared)

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

full page →fda device 510k ↗
›Jun 30, 2025device 510k431d agoOtsuka America Pharmaceutical, Inc. — Otsuka Digital Feedback Device (510k cleared)Otsuka America Pharmaceutical Inc

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

full page →fda device 510k ↗
›Jul 1, 2025approval430d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗
›Jul 1, 2025approval430d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: RUBICON RESEARCH. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗
›Jul 1, 2025device pma430d agoOrganox Limited — OrganOx metra System (PMA supplement)

Supplement type: Real-Time Process. Product code: QQK. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗
›Jul 1, 2025device pma430d agoSirtex Medical, Inc. — SIR-Spheres Y-90 resin microspheres (PMA supplement)

Supplement type: Panel Track. Product code: NAW. Advisory committee: RA. Decision: APPR

full page →fda device pma ↗
›Jul 1, 2025device pma430d agoCook Ireland, Ltd. — Zilver Flex(R) 35 Vascular Stent (PMA supplement)

Supplement type: Panel Track. Product code: NIP. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗
›Jul 1, 2025device pma430d agoTransMedics, Inc. — Organ Care System™ (OCS™) Liver (PMA supplement)TransMedics Group, Inc.

Supplement type: Real-Time Process. Product code: QQK. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗
›Jul 1, 2025device pma430d agoBoston Scientific Corp — AMS 700™ Inflatable Penile Prosthesis (IPP) with and without InhibiZone (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: JCW. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗
›Jul 1, 2025device pma430d agoABBOTT MEDICAL — HeartMate 3™ Left Ventricular Assist System (PMA supplement)

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

full page →fda device pma ↗
›Jul 1, 2025device 510k430d agoAbbott Molecular, Inc. — Alinity m CMV (510k cleared)

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k430d agoHtl-Strefa S.A — droplet® personal lancets (510k cleared)

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k430d agoAccess Vascular, Inc. — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) (510k cleared)

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k430d agoFasikl Incorporated — Felix NeuroAI System (510k cleared)

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k430d agoMedacta International S.A. — SnugFit ASA Extension (510k cleared)Stemedica International S.A.

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k430d agoCircle Cardiovascular Imaging, Inc. — StrokeSENS ASPECTS Software Application (510k cleared)

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

full page →fda device 510k ↗
$CARL
$TMO447.81+1.31%
$MCLE
$BSX48.37+0.60%
$TMDX69.43-2.72%
$BMY67.66+1.11%
$BSX48.37+0.60%