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8,689 catalysts · 3,086 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 583 earnings

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  • 8k filing3,086
  • grant1,702
  • device adverse event1,000
  • approval795
  • device 510k621
  • earnings583
device pma
467
  • device recall191
  • phase 2 completion172
  • recall162
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Feb 9, 2026

    50
    ›Feb 10, 2026approval183d agoKEYTRUDA QLEX (PEMBROLIZUMAB) — FDA approval(berahyaluronidase alfa + pembrolizumab)

    Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION

    full page →(berahyaluronidase alfa + pembrolizumab) →fda approvals ↗
    ›Feb 10, 2026approval183d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

    Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL

    full page →EVRYSDI →fda approvals ↗
    ›Feb 10, 2026approval183d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

    Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL

    full page →EVRYSDI →fda approvals ↗
    ›Feb 10, 2026approval183d agoFLUDROCORTISONE ACETATE — FDA approvalNovitium Pharma LLC

    Sponsor: HIBROW HLTHCARE. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 10, 2026approval183d agoTRETINOIN — FDA approvalMylan Pharmaceuticals Inc

    Sponsor: ENCUBE. Form: CREAM. Route: TOPICAL

    full page →fda approvals ↗
    ›Feb 10, 2026approval183d agoFLUOROURACIL — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 10, 2026approval183d agoFLUOROURACIL — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 10, 2026approval183d agoSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 10, 2026approval183d agoGLYCOPYRROLATE — FDA approvalGLYCOPYRROLATE

    Sponsor: RISING. Form: TABLET. Route: ORAL

    full page →GLYCOPYRROLATE →fda approvals ↗
    ›Feb 10, 2026approval183d agoTAPENTADOL HYDROCHLORIDE — FDA approvaltapentadol hydrochloride ER

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →tapentadol hydrochloride ER →fda approvals ↗
    ›Feb 10, 2026device 510k183d agoK2m, Inc. — Vulcan Spinal System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k183d agoFresenius Medical Care Renal Therapies Group, LLC — multiFlux 130 (F00013123); multiFlux 160 (F00013124) (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k183d agoOvigenex, LLC — CollOvine™ Wound Powder (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k183d agoFourth Axis, LLC — LANDR Contact LENS Case (510k cleared)

    Product code: LRX. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k183d agoShenzhen RF Tech Co., Ltd. — GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k183d agoCreoDent Hudson Valley — Solidex® Ti-Links and Screws (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k183d agoMedtronic Xomed, Inc. — NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080) (510k cleared)Medtronic USA Inc

    Product code: ETN. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k183d agoSiemens Medical Solutions USA, Inc. — MI View&GO (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k183d agoBiodynamik, Inc. — XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k183d agoEarflo, Inc. — Earflo (EF001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k183d agoBoston Scientific Corporation — SpaceOAR Vue System (SV-2101) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device pma183d agoMedtronic Cardiac Rhythm Disease Management — SelectSecure Lead (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d 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 ↗
    ›Feb 10, 2026device pma183d agoAlcon Research, LLC — UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System (PMA supplement)

    Supplement type: Real-Time Process. Product code: LPO. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic, Inc. — Micra AV2 TPS; Micra VR2 TPS (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoAlcon Laboratories — VISCOAT™ Ophthalmic Viscosurgical Device (PMA supplement)Alcon Laboratories Inc

    Supplement type: Normal 180 Day Track. Product code: LZP. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic, Inc. — Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01); Astra S DR MRI IPG (X3DR01); Astra S SR (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic, Inc. — Harmony™ Transcatheter Pulmonary Valve (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoBoston Scientific Corporation — TheraSphere (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoAgilent Technologies, Inc. — PD-L1 IHC 22C3 pharmDx (PMA supplement)AGILENT TECHNOLOGIES, INC.

    Supplement type: Panel Track. Product code: PLS. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic, Inc. — Aurora EV ICD DVEA3E4 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoContamac, Ltd. — Optimum Infinite (tisilfocon A) Orthokeratology Lenses II (PMA)

    Product code: NUU. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic Cardiac Rhythm Disease Management — CapSure Sense Lead 4574 CapSure Sense Lead 4073, 4074 Vitatron Crystalline Lead ICM09, ICM09B, ICM09JB Vitatron Excellen (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoABBOTT MEDICAL — Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoCooperVision, Inc. — Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoAbbott Vascular, Inc. — Perclose™ ProGlide Suture-Mediated Closure System; Perclose™ ProStyle Suture-Mediated Closure and Repair System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoABBOTT MEDICAL — Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic, Inc. — Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1T (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic, Inc. — CapSure Epicardial Pacing Lead (4965); CapSure Epicardial Pacing Lead (4968) (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic, Inc. — HV Splitter/Adaptor kit 5019 IS-1 Connector Port Pin Plug Kit 6725 Sprint Quattro Lead 6935, 6947 Sprint Quattro Lead 69 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDR06, ADDRL1, ADSR03, ADVDD01, SED01, SES01, VEDR01); Adapta, Versa, Sensia (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic, Inc. — Attain OTW LV Lead; Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Qua (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic, Inc. — Attain StarFix Lead (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic, Inc. — Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve; Medtronic Evolut™ PRO+ Transcatheter Aortic Valve; Medtroni (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoAlcon Research, LLC — UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System (PMA supplement)

    Supplement type: Real-Time Process. Product code: LPO. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic, Inc. — CapSureFix Novus Lead (5076); CapSureFix Novus Lead (4076); Vitatron Crystalline ActFix Lead (ICF09B); Vitatron Crystall (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic, Inc. — CapSure VDD-2 Lead 5038, 5038L, 5038S Service Kit-Pacemaker Repair Kit 5873C Vitatron Brilliant S+ VDD Lead IMW14Q, IMW1 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma183d agoMedtronic Cardiac Rhythm Disease Management — CapSure SP Novus Lead 5092 CapSure SP Z Lead 5033 Vitatron Impulse II Lead IHP09, IHP09B, IHP09JB (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 10, 2026device recall183d agoOrthalign, Inc device recall (Cls II)

    Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System — Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) — Status: Ongoing

    full page →fda device recalls ↗
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