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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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2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 18 catalysts2026-08-06: 11 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 2 catalysts2026-08-11: 1 catalyst2026-08-12: 2 catalysts2026-08-13: 1 catalyst2026-08-14: 1 catalyst2026-08-15: 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 catalysts2026-10-26: 0 catalysts2026-10-27: 2 catalysts2026-10-28: 1 catalyst2026-10-29: 3 catalysts2026-10-30: 0 catalysts2026-10-31: 0 catalysts2026-11-01: 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 Nov 3, 2025

    21
    ›Nov 6, 2025device 510k270d agoMedical Bees GmbH — mb-FIX Cranial Stabilization Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k270d agoStereotaxis, Inc. — Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) (510k cleared)Stereotaxis, Inc.

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k270d agoCatalyst Orthoscience, Inc. — Catalyst F1x Shoulder System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k270d agoHebei Keylaser Sci-Tech Co.,Ltd — Q-Switched Nd:Yag laser (K690) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k270d agoHubly, Inc. — Hubly Drill (H100) (510k cleared)Petros Pharmaceuticals, Inc.

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k270d agoDmp Dental Industry S.A. — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k269d agoS.I.N. Implant System Ltda — S.I.N. Tapered Pro Conical Zygoma Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k269d agoBrainsway , Ltd. — BrainsWay Deep TMS System (510k cleared)Brainsway Ltd.

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k269d agoInion OY — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k269d agoImvaria, Inc. — Fibresolve (with PCCP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k269d agoDreve Dentamid GmbH — Primeprint Direct Aligner (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k269d agoHebei Keylaser Sci-Tech Co.,Ltd — CO2 Laser Therapy System (K106) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k269d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k269d agoBaoding Te'Anzhou Electronic Technology Co., Ltd. — Medical Diode Laser Systems (VeinCure) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k269d agoRollz International BV — Electric Wheelchair (Rollz Motion Electric 2M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k269d agoUlrich GmbH & Co. KG — ulrichINJECT CT Motion (XD 8000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k269d agoPremier Dental Products Company — MultiMatch Flow Chameleon AntiMicrobial Composite (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k269d agoTopcon Corporation — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k269d agoSigma Biomedical — Triathlon Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k269d agoBench7, Inc. — SugarBug (1.x) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 9, 2025device 510k267d agoWilliam Cook Europe Aps — Lunderquist Extra Stiff Wire Guide (510k cleared)

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

    full page →fda device 510k ↗

    Week of Nov 10, 2025

    29
    ›Nov 10, 2025device 510k266d agoVesalio, Inc. — NeVasc Aspiration System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 10, 2025device 510k
    ← prev
    page 74 of 100
    next →
    266d ago
    Atlas Spine, Inc. — Atlas Spine HiRISE™ Expandable Cervical Corpectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 10, 2025device 510k266d agoMedical Microinstruments, Inc. — Symani Surgical System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 10, 2025device 510k266d agoKLS-Martin L.P. — KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 10, 2025device 510k266d agoQpix Solutions, Inc. — EzSensor HD, EzSensor UHD (510k cleared)UL Solutions Inc.

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

    full page →fda device 510k ↗
    ›Nov 10, 2025device 510k266d agoPhilips Medizin Systeme Böblingen GmbH — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 10, 2025device 510k266d agoWithings — Withings BeamO (SCT02) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2025device 510k264d agoIcotec AG — CMORE® CT System; CMORE® CT System Navigated Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2025device 510k264d agoRevmedx, Inc. — XSTAT P15 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2025device 510k264d agoIntrauma S.P.A — WRISTAR MultiAx Distal Radius Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2025device 510k264d agoEncore Medical L.P. — EMPOWR Acetabular® Liner Extension (510k cleared)Encore Medical, Inc.

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

    full page →fda device 510k ↗
    ›Nov 12, 2025device 510k264d agoSuzhou KD Intelligent Device Co., Ltd. — Powered Wheelchair (PL001-9001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2025device 510k264d agoOlympus Medical Systems Corp. — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2025device 510k264d agoETHICON, Inc. — PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2025device 510k264d agoPeek Health, S.A. — PeekMed web (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2025device 510k264d agoSynthes GmbH — Synthes Patient Specific Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2025device 510k264d agoHangzhou AGS MedTech Co., Ltd. — Hemoclip (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 13, 2025device 510k263d agoOrthosoft Inc. (d/b/a) Zimmer CAS — Rosa® Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 13, 2025device 510k263d agoFussen Technology Co., Ltd. — Dental Computed Tomography X-ray System (510k cleared)Viomi Technology Co., Ltd

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

    full page →fda device 510k ↗
    ›Nov 13, 2025device 510k263d agoAtop Lighting Co., Ltd. — LED Beauty Mask (RLBXX) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 13, 2025device 510k263d agoTelltale, LLC — TELLTALE Electrosurgical Guidewire System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 13, 2025device 510k263d agoShenzhen Future Electronic Co., Ltd. — Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 13, 2025device 510k263d agoSiemens Medical Solutions USA, Inc. — ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 13, 2025device 510k263d agoSkeletal Dynamics, Inc. — Geminus Volar Distal Radius Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2025device 510k262d agoPrinceton BioMeditech Corp. — Status™ COVID-19/Flu A&B (510k cleared)

    Product code: SCA. Advisory committee: Microbiology. Type: Dual Track

    full page →fda device 510k ↗
    ›Nov 14, 2025device 510k262d agoParagon Implant Mfg., LLC — Sterilization Trays (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2025device 510k262d agoThis AG — System Sophi (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2025device 510k262d agoKLS-Martin L.P. — KLS Martin IPS Forearm System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2025device 510k262d agoFresenius Medical Care Renal Therapies Group, LLC — AquaC UNO H (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    $BWAY
    $PTPI
    $STXS1.8800+5.62%
    $VIOT
    $FMS25.66-0.16%
    $ULS
    $EMI