Calendar

pharmadog

Week of Jan 19, 2026

Jan 22, 2026device 510k220d agoPerin Health Devices, LLC — Perin Health System (PHD80060-2) (510k cleared)

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

full page →fda device 510k ↗

Jan 22, 2026device 510k220d agoSiemens Healthcare GmbH — AI-Rad Companion Brain MR (510k cleared)

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

full page →fda device 510k ↗

Jan 22, 2026device 510k220d agoPhilips Medical Systems Nederland B.V. — AV Vascular (510k cleared)

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

full page →fda device 510k ↗

Jan 22, 2026device 510k220d agoCopan Wasp Srl — PhenoMATRIX (510k cleared)

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

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Jan 22, 2026device 510k220d agoInstitut Straumann AG — Straumann Variobase Abutments XC for Bridge/Bar (510k cleared)

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

full page →fda device 510k ↗

Jan 22, 2026device pma220d agoETHICON, Inc. — ETHIZIA Hemostatic Patch (PMA supplement)

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

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Jan 22, 2026device pma220d agoBoston Scientific Corp — Precision Spinal Cord Stimulator (SCS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

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Jan 22, 2026device pma220d agoBoston Scientific Corp — Vercise Deep Brain Stimulation (DBS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: NHL. Advisory committee: NE. Decision: OK30

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Jan 22, 2026device pma220d agoEndologix, LLC — DETOUR System (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: QWM. Advisory committee: CV. Decision: APPR

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Jan 23, 2026approval219d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

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Jan 23, 2026approval219d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

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

full page →EPYSQLI →fda approvals ↗

Jan 23, 2026approval219d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

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Jan 23, 2026approval219d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: OMNIVIUM PHARMS. Form: POWDER. Route: INTRAMUSCULAR

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Jan 23, 2026approval219d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalnaloxone hydrochloride

Sponsor: LUPIN. Form: TABLET. Route: ORAL

full page →naloxone hydrochloride →fda approvals ↗

Jan 23, 2026approval219d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalnaloxone hydrochloride

Sponsor: LUPIN. Form: TABLET. Route: ORAL

full page →naloxone hydrochloride →fda approvals ↗

Jan 23, 2026approval219d agoAFREZZA (INSULIN RECOMBINANT HUMAN) — FDA approvalinsulin human

Sponsor: MANNKIND. Form: POWDER. Route: INHALATION

full page →insulin human →fda approvals ↗

Jan 23, 2026approval219d agoJOURNAVX (SUZETRIGINE) — FDA approvalsuzetrigine

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

full page →suzetrigine →fda approvals ↗

Jan 23, 2026device 510k219d agoAb Medica Sas — Pneumo Dissector Hook (510k cleared)

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

full page →fda device 510k ↗

Jan 23, 2026device 510k219d agoRandox Laboratories Limited — Evidence MultiSTAT DOA Urine MultiPlex (510k cleared)

Product code: DJG. Advisory committee: Clinical Toxicology. Type: Traditional

full page →fda device 510k ↗

Jan 23, 2026device 510k219d agoPoint Robotics MedTech, Inc. — POINT Kinguide Agile Robotic Arm Surgical Stereotactic System (510k cleared)

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

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Jan 23, 2026device 510k219d agoDevicor Medical Products, Inc. — HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (510k cleared)UTAH MEDICAL PRODUCTS INC

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

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Jan 23, 2026device 510k219d agoBoston Scientific Cardiac Diagnostic Technologies, Inc. — BodyGuardian Remote Monitoring System (BGRMS v3.0) (510k cleared)BOSTON SCIENTIFIC CORP

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

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Jan 23, 2026device 510k219d agoBasic Medical Technology, Inc. — Syntex Exam Gloves (510k cleared)Medical Care Technologies Inc.

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

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Jan 23, 2026device 510k219d agoManteia Technologies Co., Ltd. — AccuContour 4.0 (510k cleared)

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

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Jan 23, 2026device 510k219d agoSilk Holdings, Inc. — New Day Skin Spray (510k cleared)SILGAN HOLDINGS INC

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

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Jan 23, 2026device 510k219d agoLife Spine, Inc. — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System (510k cleared)

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

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Jan 23, 2026device 510k219d agoShenzhen Rainbow Technology Co., Ltd. — LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

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Jan 23, 2026device 510k219d agoGe Healthcare Coils (Usa Instruments, Inc.) — 3.0T AIR 32CH HNA (510k cleared)

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

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Jan 23, 2026device 510k219d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) (510k cleared)

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

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Jan 23, 2026device 510k219d agoElidah, Inc. — Elitone for Men (510k cleared)

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

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Jan 23, 2026device pma219d agoMedtronic Vascular, Inc. — Protégé RX Carotid Stent System (PMA supplement)

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

full page →fda device pma ↗

Jan 23, 2026device pma219d agoMed-El Corp. — MED-EL Cochlear Implant (PMA supplement)

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

full page →fda device pma ↗

Jan 23, 2026device pma219d agoQiagen — QuantiFERON®-TB Gold Test and QuantiFERON®-TB Gold Plus Test (PMA supplement)QIAGEN N.V.

Supplement type: 30-Day Notice. Product code: NCD. Advisory committee: MI. Decision: OK30

full page →fda device pma ↗

Jan 23, 2026device pma219d agoMedtronic, Inc. — Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG (PMA supplement)Medtronic plc

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

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Jan 23, 2026device pma219d agoMedtronic, Inc. — Aurora EV-ICD System (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Jan 23, 2026device pma219d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Eve (PMA supplement)

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

full page →fda device pma ↗

Jan 23, 2026device pma219d agoMedtronic, Inc. — Percepta Bipolar CRT-P; Perceota Quadrioolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Jan 23, 2026device pma219d agoMedtronic, Inc. — Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRTP; Serena Quadripolar CRT-P; Solar (PMA supplement)Medtronic plc

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

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Jan 23, 2026device pma219d agoMedtronic Minimed — MiniMed Go app; Simplera sensor (PMA supplement)

Supplement type: Real-Time Process. Product code: MDS. Advisory committee: CH. Decision: APPR

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Jan 23, 2026device pma219d agoAdvanced Bionics — HiResolution Bionic Ear System (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: APPR

full page →fda device pma ↗

Jan 23, 2026device pma219d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt (PMA supplement)

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

full page →fda device pma ↗

Jan 23, 2026device pma219d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG; Advis (PMA supplement)Medtronic plc

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

full page →fda device pma ↗