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10,003 catalysts · 3,128 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma

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  • 8k filing3,128
  • grant2,091
  • approval1,128
  • device adverse event1,000
  • device 510k848
  • device pma610
earnings
584
  • device recall318
  • recall215
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jan 19, 2026

    50
    ›Jan 22, 2026approval202d agoROPINIROLE HYDROCHLORIDE — FDA approvalElite Laboratories Inc

    Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 22, 2026approval202d agoROPINIROLE HYDROCHLORIDE — FDA approvalElite Laboratories Inc

    Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 22, 2026approval202d agoESTRADIOL — FDA approvalestradiol ER

    Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL

    full page →estradiol ER →fda approvals ↗
    ›Jan 22, 2026device 510k202d agoImplant Protesis Dental 2004, S.L. — IPDmilled Blanks (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k202d agoLima Corporate S.P.A. — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k202d agoMaquet GmbH (A Getinge Group Company) — Getinge GSS67N Series Steam Sterilizer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k202d agoCultiv8 1, LLC — Genie MAX Large Bore Introducer Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k202d agoGeistlich Pharma AG — Device 104 Particulate (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k202d agoMedela, LLC — Pump In Style® Pro+ (510k cleared)

    Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k202d agoAstura Medical — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k202d 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 510k202d 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 510k202d 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 510k202d agoCopan Wasp Srl — PhenoMATRIX (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k202d 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 pma202d agoETHICON, Inc. — ETHIZIA™ Hemostatic Patch (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 22, 2026device pma202d 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

    full page →fda device pma ↗
    ›Jan 22, 2026device pma202d 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

    full page →fda device pma ↗
    ›Jan 22, 2026device pma202d agoEndologix, LLC — DETOUR System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 23, 2026approval201d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Jan 23, 2026approval201d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

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

    full page →EPYSQLI →fda approvals ↗
    ›Jan 23, 2026approval201d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

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

    full page →fda approvals ↗
    ›Jan 23, 2026approval201d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

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

    full page →fda approvals ↗
    ›Jan 23, 2026approval201d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalnaloxone hydrochloride

    Sponsor: LUPIN. Form: TABLET. Route: ORAL

    full page →naloxone hydrochloride →fda approvals ↗
    ›Jan 23, 2026approval201d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalnaloxone hydrochloride

    Sponsor: LUPIN. Form: TABLET. Route: ORAL

    full page →naloxone hydrochloride →fda approvals ↗
    ›Jan 23, 2026approval201d agoAFREZZA (INSULIN RECOMBINANT HUMAN) — FDA approvalinsulin human

    Sponsor: MANNKIND. Form: POWDER. Route: INHALATION

    full page →insulin human →fda approvals ↗
    ›Jan 23, 2026approval201d agoJOURNAVX (SUZETRIGINE) — FDA approvalsuzetrigine

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

    full page →suzetrigine →fda approvals ↗
    ›Jan 23, 2026device 510k201d 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 510k201d 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 510k201d agoPoint Robotics MedTech, Inc. — POINT Kinguide Agile Robotic Arm Surgical Stereotactic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k201d 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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k201d 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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k201d agoBasic Medical Technology, Inc. — Syntex Exam Gloves (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k201d agoManteia Technologies Co., Ltd. — AccuContour 4.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k201d agoSilk Holdings, Inc. — New Day Skin Spray (510k cleared)SILGAN HOLDINGS INC

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k201d 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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k201d 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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k201d agoGe Healthcare Coils (Usa Instruments, Inc.) — 3.0T AIR 32CH HNA (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k201d 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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k201d agoElidah, Inc. — Elitone for Men (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device pma201d 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 pma201d 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 pma201d 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 pma201d 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

    full page →fda device pma ↗
    ›Jan 23, 2026device pma201d 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 pma201d 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 pma201d 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 pma201d 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

    full page →fda device pma ↗
    ›Jan 23, 2026device pma201d agoMedtronic Minimed — MiniMed Go app; Simplera sensor (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 23, 2026device pma201d 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 ↗
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    page 11 of 201
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    $MDCE0.00020.00%
    $VERX12.23+0.78%
    $MNKD3.8400-2.29%
    $TEVA36.48+0.94%
    $BSX51.19+1.45%
    $CPIX7.9600+2.18%
    $BSX51.19+1.45%
    $SLGN
    $BSX51.19+1.45%
    $UTMD69.19+0.06%
    $QGEN
    $MDT90.68+1.42%
    $FRTRY
    $MDT90.68+1.42%
    $MDT90.68+1.42%
    $MDT90.68+1.42%