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12,002 catalysts · 3,415 8k filing · 2,283 grant · 1,767 approval · 1,155 device 510k · 1,000 device adverse event · 833 device pma

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  • 8k filing3,415
  • grant2,283
  • approval1,767
  • device 510k1,155
  • device adverse event1,000
  • device pma833
device recall
618
  • earnings584
  • recall266
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Dec 22, 2025

    50
    ›Dec 22, 2025approval241d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 22, 2025approval241d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 22, 2025approval241d agoLEVORPHANOL TARTRATE — FDA approvalLEVORPHANOL TARTRATE

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

    full page →LEVORPHANOL TARTRATE →fda approvals ↗
    ›Dec 22, 2025approval241d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: ANDA REPOSITORY. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 22, 2025approval241d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 22, 2025approval241d agoFENTANYL-100 (FENTANYL) — FDA approvalNiu Technologies

    Sponsor: KINDEVA. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Dec 22, 2025approval241d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: RHODES PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 22, 2025approval241d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: MIKART. Form: SOLUTION. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 22, 2025approval241d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: GENUS LIFESCIENCES. Form: SOLUTION. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 22, 2025approval241d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: GENUS LIFESCIENCES. Form: SOLUTION. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 22, 2025approval241d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 22, 2025approval241d agoLEVORPHANOL TARTRATE — FDA approvalSpecGx LLC

    Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 22, 2025device 510k241d agoRaySearch Laboratories AB (PUBL) — RayStation (2024A SP3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoTaiwan Surgical Corporation — InnoClip Clip Applier (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoTaiwan Surgical Corporation — InnoClip Disposable Clip Applier (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoIterative Health — SKOUT system (510k cleared)

    Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoOxos Medical — MC2 Portable X-ray System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoPression, Inc. — Pression Wave PRO External Counter-Pulsation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoBioticsai, Inc. — BioticsAI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoEmpatica S.r.l. — EmbraceMini (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoGlobus Medical, Inc. — HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoInstylla, Inc. — Instylla Delivery Kit (510k cleared)

    Product code: FMF. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoQingdao Kingon Medical Science and Technology Co., Ltd. — Oxygen Concentrator-P2-O5E (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoTHINK Surgical, Inc. — TMINI Miniature Robotic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoDIMPLO, Ltd. — DIMPLO Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoPhilips Ultrasound, LLC — Lumify Diagnostic Ultrasound System (510k cleared)Ocuvex Therapeutics Inc

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoETHICON, Inc. — STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoArthrex, Inc. — Syndesmosis TightRope PRO (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoZhejiang Gongdong Medical Technology Co., Ltd. — Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoAccurkardia, Inc. — AccurECG Analysis System (v2.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoEmed Technologies Corporation — Tetra (TM-20); Tetra (TM-50) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoStimlabs, LLC — Theracor (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoShenzhen Homed Medical Device Co., Ltd. — Portable oxygen concentrator (JLO-190P) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoBioteque Corporation — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoSorin Group Italia S.R.L. — Inspire HCR and HCR DUAL cardiotomy reservoirs (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoLacerta Life Science — LacertaMatrix (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoPeek Health, S.A. — PeekMed web (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoZhenjiang Assure Medical Equipment Co., Ltd. — Power wheelchair (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoCarlsmed, Inc. — aprevo® cervical plating system (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k241d agoKp Trading Co., Ltd. — KP Protective Face Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device pma241d agoMedtronic Neuromodulation — InterStim Therapy System; Verify Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 22, 2025device pma241d agoMedtronic Neuromodulation — InterStim Therapy System; Verify Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 22, 2025device pma241d agoCorcym S.r.l. — Perceval Sutureless Heart Valve (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 22, 2025device pma241d agoEdwards Lifesciences, LLC — SAPIEN M3 Transcatheter Mitral Valve Replacement System (PMA)Edwards Lifesciences Corp

    Product code: NPU. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 22, 2025device pma241d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Dec 22, 2025device pma241d agoProllenium Medical Technologies, Inc. — Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine) (PMA supplement)Medical Care Technologies Inc.

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

    full page →fda device pma ↗
    ›Dec 22, 2025device pma241d agoMedtronic Neuromodulation — Master Restore; Itrel; Synergy; Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces; Specify; and Ve (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 22, 2025device pma241d agoAtrium Medical Corp. — iCast Covered Stent System (PMA supplement)Apyx Medical Corp

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

    full page →fda device pma ↗
    ›Dec 22, 2025device pma241d agoBausch & Lomb — ADATO SIL-OL 5000 Silicone Oils (PMA supplement)Bausch & Lomb Corp

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

    full page →fda device pma ↗
    ›Dec 22, 2025device pma241d agoHeartsine Technologies, Ltd. — samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories (PMA supplement)TAT TECHNOLOGIES LTD

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

    full page →fda device pma ↗
    ← prev
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    $EW91.33-2.47%
    $MDCE0.00020.00%
    $NIU2.0599+1.47%
    $IGC0.2670+0.41%
    $GMED79.93+1.27%
    $APYX
    $CARL
    $MDT93.76+1.81%
    $BLCO17.68+3.73%
    $TATT