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5,000 catalysts · 18,987 approval · 5,256 phase readout · 5,000 device 510k · 4,728 grant · 2,539 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: 38 catalysts2026-07-31: 3 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 readout5,256
  • device 510k5,000
  • grant4,728
  • 8k filing2,539
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa319
  • therapy area

    no tagged catalysts yet

    Week of Jun 23, 2025

    50
    ›Jun 25, 2025device 510k401d agoStrait Access Technologies Holdings — SAT CenterFlow Molding Balloon Catheter (IN20-00313) (510k cleared)SS&C Technologies Holdings Inc

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoBlue Belt Technologies, Inc. — CORIOGRAPH Pre-Op Planning and Modeling Services (510k cleared)BETA Technologies, Inc.

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoPAJUNK GmbH Medizintechnologie — SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoSysmex America, Inc. — Sysmex XR-Series (XR-10) Automated Hematology Analyzer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoGeniphys, Inc. — GeniPhys Collymer Self-Assembling Scaffold (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoFisher & Paykel Healthcare, Ltd. — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) (510k cleared)

    Product code: BTT. Advisory committee: Anesthesiology. Type: Special

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoKardium, Inc. — Globe® Pulsed Field System (510k cleared)Kardigan Inc

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoAnhui Jbh Medical Apparatus Co., Ltd. — Power Wheelchair (D26) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoVerity Medical , Ltd. — NeuroTrac® MyoPlus Pro (MYO120U) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoMaxx Orthopedics, Inc. — Freedom® Total Knee System – Titanium Tibial Base Plate (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoInMode , Ltd. — Optimas MAX System (510k cleared)InMode Ltd.

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoSonic Incytes Medical Corp — Velacur One (LI-1100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoShenzhen Bestman Instrument Co., Ltd. — Doppler FHR Detector (BF-500D+, BF-560) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoJoytech Healthcare Co. , Ltd. — Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) (510k cleared)NVP Healthcare Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoNeuralytix, LLC — Neuralytix iD3 System (NTX-9001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoPathAI, Inc. — AISight Dx (510k cleared)Pathos AI Inc

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoYichang Xinxin Paper Products Co., Ltd. — Sterilization Pouch and Roll (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoHardy Diagnostics — HardyDisk AST Gepotidacin 10µg (GEP10) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoExactech, Inc. — Equinoxe® Scapula Fracture System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoOpen Implants, LLC — Sherlock (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoVioptix, Inc. — Lap.Ox™ Laparoscopic Tissue Oximeter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoTianjin Huahong Technology Co., Ltd. — safety lancet (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoAtmo Biosciences, Ltd. — Atmo Gas Capsule System (510k cleared)Brii Biosciences Ltd

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoGeistlich Pharma AG — SwissGraft X (510k cleared)

    Product code: NPM. Advisory committee: Dental. Type: Special

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoTriMed, Inc. — TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoMedtronic Sofamor Danek USA, Inc. — The Rialto™ SI Fusion System (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k400d agoChengdu Daxan Innovative Medical Tech. Co., Ltd. — Disposable Intermittent Catheter (TPU Catheter) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoPhilips Medical Systems Nederland B.V. — Philips iCT CT system (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoUstomed Instrumente Ulrich Storz GmbH & Co. KG — USTOMED Bone Fixation/Bone Augmentation Systems - PIN (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoBecton Dickinson Infusion Therapy Systems, Inc. — BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoBiomet 3i, LLC — T3 Pro Implants– ZimVie Packaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoMoon Surgical — Maestro System (REF100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoDigital Surgery Systems, Inc. (D.B.A True Digital Surgery) — Affirm 800 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoSorin Group Italia S.R.L. — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoBoston Scientific Corporation — VIKING™ Fixed Curve Diagnostic Catheter (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoMulti4 Medical AB — Multi4 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoNeuromodulatory Devices & Applications — Ampa One System (AMPA-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoSpine Wave, Inc. — Testa TP Pivoting Spacer System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoColoplast Corp. — Luja Coudé (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoGuangdong Yadeng Medical Apparatus Co., Ltd., — Integral Dental Unit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoScopio Labs , Ltd. — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoGenostis AF — Genostis Osteosynthesis System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoCenterPoint Systems, LLC — CPS Locator 3D Plus Delivery Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoYian Medical Technology (Haining) Co., Ltd. — Dental CBCT X-ray System (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoEmpnia, Inc. — eMotus Respiratory Motion Management System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoRisu Medical Technology Co., Ltd. — Diode laser device (RF3120-BI) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoDent4you AG — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoRtm Vital Signs, LLC — RTMsense Respiratory Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoMicro-Tech (Nanjing) Co., Ltd. — Disposable Distal Cap (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoPAJUNK GmbH Medizintechnologie — SonoPlex STIM; SonoPlex II (510k cleared)

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

    full page →fda device 510k ↗
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