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5,000 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,603 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: 0 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 17 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 2 catalysts2026-08-11: 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 filing2,603
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Aug 25, 2025

    48
    ›Aug 27, 2025device 510k340d agoAstra Orthomed, Inc. — Phoenix Sinus Tarsi Stent System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k340d agoBasic Medical Technology, Inc. — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k340d agoInfection Elimination Solutions, LLC — Dermalage (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k340d agoDonnevie Medical Technology (Shanghai) Co. , Ltd. — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k340d agoFysicon BV — QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k340d agoAtraverse Medical, Inc. — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k340d agoQIAGEN GmbH — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoChangsha Anxiang Medical Technology Co., Ltd. — OTC 4-Channel Rechargeable TENS Unit (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoPrior Care Science Technology, Ltd. — Medical Gas Analyzer (AG200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoAlphatec Spine, Inc. — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d ago4Dmedical Limited — CT:VQ (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoImperative Care, Inc. — Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoCompumedics Limited — Somfit D (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoImplanet — JAZZ Spinal System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoEizo Corporation — RadiForce GX570; RadiForce GX570-AR (510k cleared)

    Product code: PGY. Advisory committee: Radiology. Type: Abbreviated

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoBasic Medical Technology, Inc. — Powder-Free Vinyl Exam Gloves, clear (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoFH Industrie — JARVIS Glenoid Reverse Shoulder Prosthesis (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoIntuitive Surgical, Inc. — da Vinci SP Firefly Imaging System (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoSyrma Johari Medtech Limited — truFlex (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — SV600, SV800 Ventilator (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoGe Hualun Medical Systems Co. , Ltd. — Definium Tempo Select (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 28, 2025device 510k339d agoYpsomed AG — SmartPilot YpsoMate NS-A2.25 (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoFull Golden Biotech Corporation — FG Bone Graft B (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoCurvafix, Inc. — CurvaFix Low Profile System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoAlign Technology, Inc. — Invisalign System (510k cleared)ALIGN TECHNOLOGY INC

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoNeurotronics, LLC — PV01 PVDF Effort Sensor (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoMedtronic Minimed, Inc. — SmartGuard technology; Predictive Low Glucose technology (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoLima Corporate S.P.A. — ArTT Augments and Buttresses and Bone Screws (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoTrinity Medical Solutions — Regenesis EMS Chair (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoErbe Elektromedizin GmbH — Erbe ESU Model VIO® 3n with Accessories (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoTwinsight — SurgiTwin (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoEpic Medical Pte. , Ltd. — EZ™ IV Administration Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoTouchbeauty Beauty & Health (Shenzhen) Co., Ltd. — GLAM LED Facial Mask (TB-2386F) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoK&J Consulting — IVA & AEON Cervical and Lumbar Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoCooperSurgical, Inc. — Fetal Pillow (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoFUJIFILM Sonosite, Inc. — Sonosite LX and Sonosite PX Ultrasound Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoGC America, Inc. — G aenial Universal Injectable II (510k cleared)PARKS AMERICA, INC

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoMerit Medical Ireland, Ltd. — Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoEdwards Lifesciences — Edwards eSheath Optima introducer set (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoSunrise SA — Sunrise (510k cleared)Sunrise Pharmaceutical Inc

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoRaumedic AG — NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoDentsply Sirona, Inc. — Primescan 2 (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoGeneseeq Technology, Inc. — GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) (510k cleared)GSI TECHNOLOGY INC

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoNurea — PRAEVAorta®2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoPrecision Robotics (Hong Kong) Limited — SIRIUS Endoscope System (PR-SI-1230) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 29, 2025device 510k338d agoPerfuze, Ltd. — Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set (510k cleared)

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

    full page →fda device 510k ↗

    Week of Sep 1, 2025

    2
    ›Sep 2, 2025device 510k334d agoBelport Company, Inc., Gingi-Pak — RODIN Cement (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 2, 2025device 510k
    ← prev
    page 61 of 100
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    334d ago
    Chengdu Besmile Medical Technology Co., Ltd. — Customized Abutment and Screw (510k cleared)

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

    full page →fda device 510k ↗
    $ISRG353.33+0.10%
    $MDCE0.00020.00%
    $ALGN
    $EW91.33-2.47%
    $XRAY13.37-2.69%
    $TMO447.81+1.31%
    $MDCE0.00020.00%
    $ISRG353.33+0.10%
    $PRKA
    $GSIT