Calendar · pharmadog

Sign In Subscribe

Week of Mar 23, 2026

50

Mar 26, 2026device 510k144d agoDevilbiss Healthcare, LLC — DeVilbiss 5 Liter Oxygen Concentrator (555) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device 510k144d agoShenzhen Urion Technology Co., Ltd. — Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗

Mar 26, 2026device 510k144d agoAirs Medical, Inc. — SwiftMR (510k cleared)AVITA Medical, Inc.

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

full page →fda device 510k ↗

Mar 26, 2026device 510k144d agoRestore Robotics — Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device pma144d agoMedinol, Ltd. — EluNIR Ridaforolimus Eluting Coronary Stent System (PMA supplement)IGC Pharma, Inc.

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

full page →fda device pma ↗

Mar 26, 2026device pma144d agoMedtronic Neuromodulation — Altaviva (PMA supplement)

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

full page →fda device pma ↗

Mar 26, 2026device pma144d agoBolton Medical, Inc. — TREO® Abdominal Stent-Graft System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MIH. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Mar 26, 2026grant144d agoMEDICAL UNIVERSITY OF SOUTH CAROLINA — Data Analytics Training And Professional Development (DATA-Pro) for Behaviora...

CA grant. $215,976. PI: Kalyani Sonawane

full page →nih reporter ↗

Mar 26, 2026grant144d agoUNIVERSITY OF CALIFORNIA, SAN DIEGO — The Impact of Bile Salt Hydrolase on Intestinal T Cells in ColitisUniversity of California San Diego

DK grant. $43,313. PI: Elizabeth A Brown

full page →nih reporter ↗

Mar 26, 2026grant144d agoOREGON HEALTH & SCIENCE UNIVERSITY — A microphysiological model of prostate cancer metastasis into vascularized an...

CA grant. $521,002. PI: Luiz Eduardo Bertassoni

full page →nih reporter ↗

Mar 26, 2026grant144d agoOREGON HEALTH & SCIENCE UNIVERSITY — Direct and indirect MCL1 targeting for high-efficiency therapy of lung metast...

CA grant. $625,179. PI: Alexander E Davies

full page →nih reporter ↗

Mar 27, 2026approval143d agoEPKINLY (EPCORITAMAB-BYSP) — FDA approvalepcoritamab

Sponsor: GENMAB US, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →epcoritamab →fda approvals ↗

Mar 27, 2026approval143d agoALYFTREK (DEUTIVACAFTOR) — FDA approval(deutivacaftor + tezacaftor + vanzacaftor calcium)

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →(deutivacaftor + tezacaftor + vanzacaftor calcium) →fda approvals ↗

Mar 27, 2026approval143d agoALLI (ORLISTAT) — FDA approvalH2-Pharma LLC

Sponsor: HALEON US HOLDINGS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoPONLIMSI (DENOSUMAB-ADET) — FDA approvalPONLIMSI

Sponsor: TEVA PHARMACEUTICALS, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →PONLIMSI →fda approvals ↗

Mar 27, 2026approval143d agoZEJULA (NIRAPARIB TOSYLATE) — FDA approvalniraparib

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →niraparib →fda approvals ↗

Mar 27, 2026approval143d agoDAYBUE (TROFINETIDE) — FDA approvaltrofinetide

Sponsor: ACADIA PHARMS INC. Form: SOLUTION. Route: ORAL

full page →trofinetide →fda approvals ↗

Mar 27, 2026approval143d agoCARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER (NICARDIPINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: CHIESI. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Mar 27, 2026approval143d agoDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ATROPINE SULFATE) — FDA approvalATROPINE SULFATE

Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

full page →ATROPINE SULFATE →fda approvals ↗

Mar 27, 2026approval143d agoASENAPINE MALEATE — FDA approvalASENAPINE MALEATE

Sponsor: SIGMAPHARM LABS LLC. Form: TABLET. Route: SUBLINGUAL

full page →ASENAPINE MALEATE →fda approvals ↗

Mar 27, 2026approval143d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

Mar 27, 2026approval143d agoHALOPERIDOL DECANOATE — FDA approvalHALOPERIDOL DECANOATE

Sponsor: MANKIND PHARMA. Form: INJECTABLE. Route: INJECTION

full page →HALOPERIDOL DECANOATE →fda approvals ↗

Mar 27, 2026approval143d agoSPINRAZA (NUSINERSEN SODIUM) — FDA approvalBIOGEN INC.

Sponsor: BIOGEN IDEC. Form: SOLUTION. Route: INTRATHECAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoLICART (DICLOFENAC EPOLAMINE) — FDA approvalAmzell Limited

Sponsor: IBSA INST BIO. Form: SYSTEM. Route: TOPICAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

Sponsor: VERTEX PHARMS INC. Form: GRANULES. Route: ORAL

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoKETAMINE HYDROCHLORIDE — FDA approvalKetalar

Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

full page →Ketalar →fda approvals ↗

Mar 27, 2026approval143d agoCLADRIBINE — FDA approvalMerck KGaA

Sponsor: HOPEWELL PHARMA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026device 510k143d agoCanon Medical Systems Corporation — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoButterfly Network, Inc. — Butterfly Gestational Age Tool (510k cleared)Butterfly Network, Inc.

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoSS GLOBAL — CyClean Cord (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoETHICON, Inc. — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoSamsung Medison Co., Ltd. — EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoVy Spine, LLC — VyPlate Anterior Cervical Plate System (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoFoshan Dahao Medical Technology Co., Ltd. — Electric wheelchair (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoMedcad — MedCAD® AccuStride System (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoStreck, LLC — MDx-Chex for BCP (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoPhilips Medical Systems Technologies , Ltd. — Spectral CT Verida Family (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoAmerican Medical Endoscopy, Inc. — Strauss Surgical cystoscope, hysteroscope and accessories Instruments (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoEsaote, S.p.A. — S-scan Open (100001800) (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoAneuvo — ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) (510k cleared)

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

full page →fda device 510k ↗

page 33 of 160