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5,000 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,580 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 0 catalysts2026-07-29: 0 catalysts2026-07-30: 0 catalysts2026-07-31: 20 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 16 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 1 catalyst2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 1 catalyst2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 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: 0 catalysts2026-08-27: 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: 0 catalysts2026-09-04: 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: 0 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: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 0 catalysts2026-10-20: 1 catalyst2026-10-21: 1 catalyst2026-10-22: 2 catalysts2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,347
  • device 510k5,000
  • grant4,728
  • 8k filing2,580
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Jul 28, 2025

    12
    ›Aug 1, 2025device 510k365d agoAIRS, Inc. — RONAVIS – FX (FX-001) (510k cleared)AIRWA INC.

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

    full page →fda device 510k ↗
    ›Aug 1, 2025device 510k365d agoVantive US Healthcare, LLC — AK 98 Dialysis Machine (955607) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 1, 2025device 510k365d agoAvizor S.A. — MINI VP1 (PL67_F); MINI VP1 (PL61_F) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 1, 2025device 510k365d agoEpic Medical Pte. , Ltd. — eZSURE™ Empty Fluid Container (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 1, 2025device 510k365d agoBeckman Coulter, Inc. — Access hsTnI (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 1, 2025device 510k365d agoExactech, Inc. — Equinoxe® Shoulder System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 1, 2025device 510k365d agoDk Medical Systems Co., Ltd. — INNOVISION-DXII (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 1, 2025device 510k365d agoPearl Diagnostics, Inc. — MycoMEIA Aspergillus Assay (510k cleared)Co-Diagnostics, Inc.

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

    full page →fda device 510k ↗
    ›Aug 1, 2025device 510k365d agoDeepSight Technology, Inc. — Deepsight NeedleVue LC1 Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 1, 2025device 510k365d agoAccess Vascular, Inc. — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 1, 2025device 510k365d agoAmerican Medical Endoscopy, Inc. — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 1, 2025device 510k365d agoDentalhitec — QuickSleeper 5 (510k cleared)

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

    full page →fda device 510k ↗

    Week of Aug 4, 2025

    38
    ›Aug 4, 2025device 510k362d agoTerragene — Terragene® Bionova® BT20 Biological Indicator (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 4, 2025device 510k
    ← prev
    page 57 of 100
    next →
    362d ago
    Spectrum Medical S.R.L. — Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 4, 2025device 510k362d agoAndon Health Co, Ltd. — iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 4, 2025device 510k362d agoOkapi Medical, LLC Dba Resivant Medical — CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 4, 2025device 510k362d agoDaxor Corporation — Blood Volume Analyzer (200) (510k cleared)DAXOR CORP

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

    full page →fda device 510k ↗
    ›Aug 4, 2025device 510k362d agoH&abyz Co., Ltd. — HnX-P1, HnX-PB (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 5, 2025device 510k361d agoNanosonics — trophon2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 5, 2025device 510k361d agoShanghai United Imaging Healthcare Co., Ltd. — uMR Jupiter (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 5, 2025device 510k361d agoEncore Medical L.P. — AltiVate Reverse® Glenoid (510k cleared)Encore Medical, Inc.

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

    full page →fda device 510k ↗
    ›Aug 5, 2025device 510k361d agoClaritas Healthtech Pte, Ltd. — iPETcertum (v1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 5, 2025device 510k361d agoSimplivia Healthcare , Ltd. — Chemfort Female Luer Lock Adaptor (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 5, 2025device 510k361d agoBethesda Medical Devices — PRADO™ Lumbar Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 5, 2025device 510k361d agoRespiree Pte, Ltd. — Respiree Cardio- Respiratory Monitor System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 6, 2025device 510k360d agoHangzhou Viction Medical Technology Co.,Ltd — Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 6, 2025device 510k360d agoTecres S.P.A. — InterSpace GV Hip Spacer (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 6, 2025device 510k360d agoPhilips France Commercial — Cardiologs Holter Platform (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 6, 2025device 510k360d agoIntegra Lifesciences Production Corporation — Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 6, 2025device 510k360d agoHangzhou Viction Medical Technology Co.,Ltd — Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 6, 2025device 510k360d agoShen Zhen Cambridge-Hit Co., Ltd. — Digital Radiographic Imaging Acquisition Software - DR (RiasDR) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 6, 2025device 510k360d agoEl.En S.P.A. — Olo (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 6, 2025device 510k360d agoAevumed, Inc. — Aevumed PHANTOM Suture Anchors (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 6, 2025device 510k360d agoTandem Diabetes Care — SteadiSet infusion set (510k cleared)TANDEM DIABETES CARE INC

    Product code: FPA. Advisory committee: General Hospital. Type: Abbreviated

    full page →fda device 510k ↗
    ›Aug 6, 2025device 510k360d agoImris Imaging, Inc. — InVision™ 3T Recharge Operating Suite (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 6, 2025device 510k360d agoMicrolife Corporation — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 7, 2025device 510k359d agoBTL Industries, Inc. — BTL-199 (510k cleared)NL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›Aug 7, 2025device 510k359d agoOrtho Solutions UK , Ltd. — Succession™ AFN System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 7, 2025device 510k359d agoSignature Orthopaedics Pty, Ltd. — Longboard Revision Hip Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 7, 2025device 510k359d agoShenzhen Liyoutong Technology Co., Ltd. — LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Aug 7, 2025device 510k359d agoMedicrea International S.A.S. (Medtronic) — UNiD™ Spine Analyzer (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 7, 2025device 510k359d agoBoston Scientific Neuromodulation Corporation — GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Aug 7, 2025device 510k359d agoUC-CARE , Ltd. — Navigo Workstation 2.3 (FPRMC00039) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 7, 2025device 510k359d agoSentec AG — LuMon(TM) System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k358d agoVive Health, LLC — Coretech Compression System (Coretech RHB3003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k358d agoAqua Medical, Inc. — Aqua Medical RF Vapor Ablation System (510k cleared)AVITA Medical, Inc.

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k358d agoParkell, Inc. — Parkell Pit and Fissure Sealant (510k cleared)

    Product code: EBC. Advisory committee: Dental. Type: Abbreviated

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k358d agoIntegra Lifesciences Production Corporation — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k358d agoEmblation Limited — swiftPro System (SWF-SPS); Swift System (SWF-SYS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k358d agoElevation Spine — SABER-C System (510k cleared)

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

    full page →fda device 510k ↗
    $YYAI
    $CODX1.5600+3.31%
    $FRTRY
    $EMI
    $DXR
    $TNDM19.01+2.26%
    $NL6.0500-1.14%
    $BSX46.00-0.09%
    $RCEL4.4900+1.13%