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5,000 catalysts · 18,987 approval · 5,811 phase readout · 5,000 device 510k · 4,728 grant · 2,966 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 0 catalysts2026-08-05: 0 catalysts2026-08-06: 0 catalysts2026-08-07: 16 catalysts2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 10 catalysts2026-08-11: 6 catalysts2026-08-12: 12 catalysts2026-08-13: 10 catalysts2026-08-14: 3 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 0 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: 0 catalysts2026-08-28: 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: 0 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: 9 catalysts2026-10-29: 17 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,811
  • device 510k5,000
  • grant4,728
  • 8k filing2,966
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings469
  • therapy area

    no tagged catalysts yet

    Week of Feb 9, 2026

    10
    ›Feb 13, 2026device 510k176d agoContour Research, LLC — Contour Light (CL-100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k176d agoJoytech Healthcare Co. , Ltd. — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) (510k cleared)NVP Healthcare Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k176d agoMedela, LLC — Motion InBra (YM-8801) wearable breast pump (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k176d agoDrägerwerk AG & Co. KGaA — Babyleo TN500 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k176d agoMeasure Labs, Inc. (Dba Preemptiveai, Inc.) — PreemptiveAI Clinical SDK (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k176d agoShenzhen Hingmed Medical Instrument Co., Ltd. — Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k176d agoVPIX Medical, Inc. — cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) (510k cleared)VYCOR MEDICAL INC

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k176d agoMerit Medical Systems, Inc. — STAR RF Ablation System (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k176d agoBayer Medical Care, Inc. — MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k176d agoArbor Endovascular, LLC — Willow 18 Guidewire (510k cleared)

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

    full page →fda device 510k ↗

    Week of Feb 16, 2026

    40
    ›Feb 17, 2026device 510k172d agoBiomendex OY — Adaptos®Fuse Bone Graft (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k
    ← prev
    page 90 of 100
    next →
    172d ago
    Liquet Medical, Inc. — Versus™ Catheter (VS110-9NB) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k172d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k172d agoBiocomposites, Ltd. — Biosteon® Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k172d agoFujifilm Corporation — FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k172d agoNingbo Shenyu Medical Equipment Co.,Ltd — Electric Wheelchair (W-A807, W-A807L) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k172d agoCenterline Biomedical, Inc. — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2026device 510k171d agoStryker Endoscopy — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2026device 510k171d agoAxis-Shield Diagnostics, Ltd. — Alere NT-proBNP for Alinity i (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2026device 510k171d agoBTL Industries, Inc. — BTL-754FF (510k cleared)NL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›Feb 18, 2026device 510k171d agoNobel Biocare AB — Nobel Biocare S Series Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2026device 510k171d agoHowmedica Osteonics Corp., Dba Stryker Orthopaedics — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2026device 510k171d agoShenzhen Zhimahuaerkai Technology Co., Ltd. — Mobility Scooter (S3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2026device 510k171d agoMethyl Co., Ltd. — PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoMiRus, LLC — ATLAS™ Expandable Osteotomy Wedge System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoErchonia Corporation — Erchonia DPN Laser (Model# EVRL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoAlphatec Spine, Inc. — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoGM Dos Reis Industria e Comercio Ltda. — Meniscus Versaflex (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoEsthetic Medical, Inc. — SkinStylus SteriLock MicroSystem (MP1209SL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoAS Software, LLC — AS Software Version Asera (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoSilony Medical GmbH — VERTICALE GPS Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoElekta Solutions AB — Monaco RTP System (6.3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoEfofex, Inc. — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoBeckman Coulter, Inc. — Access anti-HBc Total (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoGuilin Refine Medical Instrument Co., Ltd. — Portable Dental X-ray Device (GT-1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoLacerta Life Sciences — LacertaMatrix (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoStryker Leibinger GmbH & Co KG — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoAcclarent, Inc. — Acclarent AERA Eustachian Tube Balloon Dilation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoCMT Health PTE., Ltd. — Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoAdaptiiv Medical Technologies, Inc. — TrueFit Bolus (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoMedtronic, Inc. — Retrograde Coronary Sinus Perfusion Cannulae (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k170d agoCenterPoint Systems, LLC — AuST CSP Introducer (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k169d agoSoterix Medical, Inc. — SPRY TMS Therapy System (0550) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k169d agoForeo, Inc. — FAQ™ (LED Panel); FAQ™ (Dual LED Panel) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k169d agoKLS Martin L.P. — KLS Martin Ixos System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k169d agoCepheid — Xpert Hemorrhagic Fever (510k cleared)

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k169d agoIntertape Polymer Group — LF Process Indicator Tape for Steam Sterilization (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k169d agoZhejiang Chuangxiang Medical Technology Co., Ltd. — Disposable Ureteral Stents (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k169d agoBd — BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k169d agoPoint Robotics MedTech, Inc. — “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set (510k cleared)

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

    full page →fda device 510k ↗
    $VYCO0.06600.00%
    $MMSI88.22+0.61%
    $MDCE0.00020.00%
    $MDT85.91-0.02%
    $NL6.0500-1.14%