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632 catalysts · 3,045 8k filing · 1,751 grant · 1,000 device adverse event · 820 approval · 632 device 510k · 578 earnings

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2026-08-10: 0 catalysts2026-08-11: 16 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 20 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 8 catalysts2026-11-03: 17 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device 510k×from 2026-02-04×clear all
type
  • 8k filing3,045
  • grant1,751
  • device adverse event1,000
  • approval820
  • device 510k632
  • earnings578
device pma
481
  • device recall194
  • phase 2 completion172
  • recall167
  • therapy area

    no tagged catalysts yet

    Week of Feb 2, 2026

    32
    ›Feb 4, 2026device 510k188d agoOrthosoft Inc. (d/b/a) Zimmer CAS — Signature™ ONE System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k188d agoSpinal Elements, Inc. — Luna® Ti Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k188d agoBard Peripheral Vascular, Inc. — UltraScore™ Focused Force PTA Balloon (510k cleared)

    Product code: PNO. Advisory committee: Cardiovascular. Type: Special

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k188d agoZimmer, Inc. — G7® Revision Acetabular System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k188d agoYadu Medical (Henan) Co., Ltd. — Henan Yadu Level 4 Surgical Gowns (Reinforced) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k188d agoEvolution Spine — E3D™-C Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k187d agoEncora, Inc. — Encora X1 (510k cleared)Encore Inc.

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k187d agoDentsply Sirona — Primevision 3D (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k187d agoGe Medical Systems, LLC — SIGNA™ Sprint Select (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k187d agoPenumbra, Inc. — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK (510k cleared)Penumbra Inc

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k187d agoArgon Medical Devices, Inc. — CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister (510k cleared)

    Product code: QEW. Advisory committee: Cardiovascular. Type: Special

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoAthelas, Inc. — Athelas Home (510k cleared)

    Product code: GKZ. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoK2m, Inc. — Q Interbody Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoQuantel Medical — INTEGRE LIO (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoEieling Technology (Shenzhen) Limited — Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoGe Medical Systems, LLC — SIGNA™ Bolt (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoSiemens Healthcare Diagnostics, Inc. — Atellica® IM TSH3-Ultra II (TSH3ULII) (510k cleared)

    Product code: JLW. Advisory committee: Clinical Chemistry. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoStryker Leibinger GmbH & Co KG — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoUzinmedicare Co., Ltd. — Spectra S1 Pro; Spectra S2 Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoLive Medica, LLC — LiveMedica Enterprise PACS (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoFujifilm Corporation — Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoSafeBeat Rx, Inc. — SafeBeat Rx App (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoMedian Technologies — Median LCS (internal name) / eyonis LCS (trade name) (1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoPhilips Medizin Systeme Boeblingen GmbH — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoShenzhen Gsd Technology Co., Ltd. — Dermatrix Duo (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoKneevoice, Inc. — Kneevoice Cartilage Evaluation System (750-3600-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoDentsply Sirona, Inc. — Stainless Steel Surgical Kits (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoETHICON, Inc. — MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoInova Diagnostics, Inc. — Aptiva APS IgA Reagent (510k cleared)Co-Diagnostics, Inc.

    Product code: MSV. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoAmferia AB — Amferia Wound Dressing (510k cleared)

    Product code: SHA. Advisory committee: General, Plastic Surgery. Type: Direct

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoAugmented Reality Software S.L. — LAIA XR (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoBalmoral Medical, LLC — ROSA Knee System with UltraSound Imaging Platform (USIP) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Feb 9, 2026

    18
    ›Feb 9, 2026device 510k183d agoVascuTech Medical, LLC — Peel-Away Introducer Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 9, 2026device 510k
    ← prev
    page 1 of 13
    next →
    183d ago
    Edan Instruments, Inc. — Holter ECG and ABP system (HolterABP) (510k cleared)VEECO INSTRUMENTS INC

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

    full page →fda device 510k ↗
    ›Feb 9, 2026device 510k183d agoCeribell, Inc. — Ceribell Instant EEG Headset (510k cleared)Ceribell, Inc.

    Product code: GXY. Advisory committee: Neurology. Type: Abbreviated

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k182d agoK2m, Inc. — Vulcan Spinal System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k182d 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 510k182d agoOvigenex, LLC — CollOvine™ Wound Powder (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k182d 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 510k182d 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 510k182d 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 510k182d 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 510k182d 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 510k182d 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 510k182d agoEarflo, Inc. — Earflo (EF001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k182d 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 11, 2026device 510k181d agoStryker Neurovascular — AXS Lift Intracranial Base Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2026device 510k181d agoAi4medimaging Medical Solutions S.A. — AI4CMR v2.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2026device 510k181d agoSI-BONE, Inc. — iFuse INTRA Ti™ Implant System (510k cleared)SI-BONE, Inc.

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

    full page →fda device 510k ↗
    ›Feb 11, 2026device 510k181d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    $ECR
    $XRAY11.66-3.80%
    $FRTRY
    $XRAY11.66-3.80%
    $CODX1.51000.00%
    $VECO59.42+2.95%
    $PEN324.29-0.11%
    $FMS24.35+0.33%
    $BSX50.46+2.33%
    $SIBN13.41+15.55%
    $CBLL19.55-2.25%