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5,000 catalysts · 18,987 approval · 5,063 phase readout · 5,000 device 510k · 4,728 grant · 2,464 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 26 catalysts2026-07-29: 12 catalysts2026-07-30: 12 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 12 catalysts2026-08-05: 14 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: 0 catalysts2026-08-14: 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: 0 catalysts2026-10-22: 1 catalyst2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,063
  • device 510k5,000
  • grant4,728
  • 8k filing2,464
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings296
  • therapy area

    no tagged catalysts yet

    Week of May 12, 2025

    50
    ›May 12, 2025device 510k443d agoC.E.I.B.Med — Reon (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k443d agoSignature Orthopaedics Pty, Ltd. — Shoulder Soft Tissue Anchors (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k443d agoP-Cure, Ltd. — P-Cure Proton Therapy System (PPTS) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k443d agoShanghai United Imaging Healthcare Co., Ltd. — uWS-Angio Basic (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k443d agoApyx Medical Corporation — AYON Body Contouring System (AYON SYSTEM) (510k cleared)Apyx Medical Corp

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k443d agoHeidelberg Engineering GmbH — SPECTRALIS HRA+OCT and variants (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k443d ago3D-Side — Archer PSI System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k443d agoInari Medical, Inc. — InThrill™ Thrombectomy System (510k cleared)Mobia Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 13, 2025device 510k442d agoSignature Orthopaedics Pty, Ltd. — Freedom Posterior Cervical Screws (510k cleared)

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

    full page →fda device 510k ↗
    ›May 13, 2025device 510k442d agoIntuitive Surgical, Inc. — SP Endoscope, 0° (430600) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›May 13, 2025device 510k442d agoCanon Medical Systems Corporation — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 13, 2025device 510k442d agoUlthera, Inc. — Ulthera System (UC-1 Control Unit PRIME Model 2.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 13, 2025device 510k442d agoAesculap, Inc. — Aesculap Aicon® Series Container System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 13, 2025device 510k442d agoPromisemed Hangzhou Meditech Co., Ltd. — Promisemed Safety Huber Needles (510k cleared)

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

    full page →fda device 510k ↗
    ›May 14, 2025device 510k441d agoTheranica Bio-Electronics, Ltd. — Nerivio; Nerivio Infinity (510k cleared)

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

    full page →fda device 510k ↗
    ›May 14, 2025device 510k441d agoShenzhen Trious Medical Technology Co., Ltd. — Disposable ureteral stent (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›May 14, 2025device 510k441d agoTrax Surgical — Linkt Compression Staple System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 14, 2025device 510k441d agoShanghai United Imaging Healthcare Co., Ltd. — Medical Image Post-processing Software (uOmnispace.CT) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 14, 2025device 510k441d agoZhengzhou PZ Laser Slim Technology Co., Ltd. — Medical Picosecond ND: YAG Laser System (PZ-6) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 14, 2025device 510k441d agoWontech Co., Ltd. — Veincare (510k cleared)

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

    full page →fda device 510k ↗
    ›May 14, 2025device 510k441d agoTribun Health — CaloPix (510k cleared)

    Product code: QKQ. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›May 14, 2025device 510k441d agoTaizhou Reach Technology Co., Ltd. — Magnesium alloy scooter (RS100) (510k cleared)Tsuno Rice Fine Chemicals Co Ltd

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

    full page →fda device 510k ↗
    ›May 14, 2025device 510k441d agoHelios Biomedical, Inc. — Helios Dura Regeneration Matrix (510k cleared)RNR BioMedical Inc

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

    full page →fda device 510k ↗
    ›May 14, 2025device 510k441d agoCeraroot SL — CeraRoot TL Implant System (TL) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 14, 2025device 510k441d agoAscensia Diabetes Care U.S., Inc. — MICROLET®NEXT 2 Lancing Device (510k cleared)

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

    full page →fda device 510k ↗
    ›May 14, 2025device 510k441d agoEthicon Endo-Surgery, LLC — ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 14, 2025device 510k441d agoCube Click, Inc. — Smile Dx® (510k cleared)

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

    full page →fda device 510k ↗
    ›May 14, 2025device 510k441d agoImperative Care, Inc. — Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoNIKKISO CO., LTD. — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoStryker Instruments — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoC.R. Bard, Inc. — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoNeuraxis — NeurAxis IB-Stim (01-1020) (510k cleared)Neuraxis, INC

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoWe Medical Technology (Wuxi) Co., Ltd. — Youmagic FLM System (YM5-U1) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoEdwards Lifesciences, LLC — Hypertension Prediction Index (HePI) Algorithm (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoGuard Medical, Inc. — NPseal (510k cleared)Picard Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoEywa Srl — Limfa Therapy System (Limfa Therapy) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoOlympus Medical Systems Corporation — Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoNIKKISO CO., LTD. — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoNIKKISO CO., LTD. — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoEmbolization, Inc. — Nitinol Enhanced Device (NED) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoMekics Co., Ltd. — HFT750U (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoHardy Diagnostics — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) (510k cleared)Bristol-Myers Squibb Co

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoPhilips Ultrasound — Lumify Diagnostic Ultrasound System (510k cleared)Ocuvex Therapeutics Inc

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k440d agoMicroport Orthopedics, Inc. — NEXUS® Hip Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k439d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6); (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k439d agoBrainlab AG — Mixed Reality Spine Navigation (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k439d agoCellah Medical Co., Ltd. — BLESSING System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k439d agoVenocare, Inc. — Ruby Intravascular Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k439d agoIorbit Digital Technologies Private Limited — iBSM (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k439d agoMedicatech USA, Inc. — MasteRad MiniX Mobile Digital Imaging System (Mini-X) (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $APYX
    $NRXS
    $MOBI
    $ISRG365.27+2.37%
    $PMI0.1821-4.66%
    $EW91.33-2.47%