Calendar

pharmadog

Jan 2, 2026approval221d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jan 2, 2026approval221d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalPERRIGO Co plc

Sponsor: TARO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 2, 2026approval221d agoEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) — FDA approvalEXTENDED PHENYTOIN SODIUM

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

full page →EXTENDED PHENYTOIN SODIUM →fda approvals ↗

Jan 2, 2026approval221d agoHYDROCODONE BITARTRATE AND ASPIRIN (ASPIRIN) — FDA approvalPurdue Pharma LP

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

full page →fda approvals ↗

Jan 2, 2026device 510k221d agoOrthocon, Inc. — MONTAGE XT Cranial Cement (510k cleared)

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

full page →fda device 510k ↗

Jan 2, 2026device 510k221d agoJamjoom Fullcare Corporation — Ready to use Nelaton Catheter (510k cleared)

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

full page →fda device 510k ↗

Jan 2, 2026device 510k221d agoNingbo Baichen Medical Devices Co., Ltd. — Mobility Scooter (BC-MS310) (510k cleared)

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

full page →fda device 510k ↗

Jan 2, 2026device 510k221d agoZuriMED Technologies AG — FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit (510k cleared)

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

full page →fda device 510k ↗

Jan 2, 2026device pma221d agoMentor Corp. — MENTOR MemoryGel Silicone Gel-Filled Breast Implants (PMA supplement)

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

full page →fda device pma ↗

Jan 2, 2026device pma221d agoBoston Scientific Corporation — Bulkamid Urethral Bulking System (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Jan 2, 2026device pma221d agoBiosense Webster, Inc. — VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump (PMA supplement)

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

full page →fda device pma ↗

Jan 2, 2026device pma221d agoMentor Worldwide, LLC — MENTOR MemoryShape Breast Implants (PMA supplement)

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

full page →fda device pma ↗

Jan 2, 2026device recall221d agoAVID Medical, Inc. device recall (Cls II)AVITA Medical, Inc.

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01. — Reason: Tyvek bag seal issue which may compromise sterility of the kit. — Status: Ongoing

full page →fda device recalls ↗

Jan 2, 2026device recall221d agoAlphatec Spine, Inc. device recall (Cls II)

ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker. — Reason: Due a design issue where the navigated array connection geometry is incorrect. — Status: Ongoing

full page →fda device recalls ↗

Jan 2, 2026device recall221d agoAlphatec Spine, Inc. device recall (Cls II)

ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker. — Reason: Due a design issue where the navigated array connection geometry is incorrect. — Status: Ongoing

full page →fda device recalls ↗

Jan 2, 2026grant221d agoSTATE UNIVERSITY NEW YORK STONY BROOK — The Role of MEF2A in the Selective Vulnerability of Dopamine Neurons in Parki...

NS grant. $42,647. PI: Colista Sue West

full page →nih reporter ↗

Week of Dec 29, 2025