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5,000 catalysts · 18,987 approval · 5,720 phase readout · 5,000 device 510k · 4,728 grant · 2,952 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,720
  • device 510k5,000
  • grant4,728
  • 8k filing2,952
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings409
  • therapy area

    no tagged catalysts yet

    Week of Jan 26, 2026

    3
    ›Jan 30, 2026device 510k189d agoSorin Group Italia S.R.L. — Dual Stage Venous Cannulae (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k189d agoAsistan Medikal — Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2026device 510k188d agoMerit Medical Ireland, Ltd. — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Feb 2, 2026

    47
    ›Feb 2, 2026device 510k186d agoNano-X Imaging , Ltd. — TAP2D (510k cleared)Nano-X Imaging Ltd.

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

    full page →fda device 510k ↗
    ›Feb 2, 2026device 510k
    ← prev
    page 88 of 100
    next →
    186d ago
    Chengdu Besmile Medical Technology Co., Ltd. — BIORES Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 2, 2026device 510k186d agoOxehealth Limited — Vital Signs (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 2, 2026device 510k186d agoBeijing Kreate Medical Co., Ltd. — Redermax Antibacterial Wound Matrix (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 2, 2026device 510k186d agoAsahi Intecc Co., Ltd. — CHIKAI Nexus petit (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k185d agoApplied Medical Technology, Inc. — Explant Express (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k185d agoDror Orthodesign , Ltd. — ZSmile System (510k cleared)Dror Ortho-Design, Inc.

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k185d agoStryker GmbH — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (510k cleared)STRYKER CORP

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k185d agoNingbo Runyes Medical Instrument Co., Ltd. — Diagnostic X-Ray Equipment Model POCT22 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k185d agoCircadia Health, Inc. — The Circadia C300 System (C300) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k185d agoMedtronic Minimed — SmartGuard Technology; Predictive Low Glucose Technology (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k185d agoUlrich Medical USA, Inc. — Navigation Module of the Cortium® System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k185d agoXi'An Taibo Electronic Technology Co., Ltd. — 808nm semiconductor laser hair removal machine (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k185d agoDexcom, Inc. — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (510k cleared)DEXCOM INC

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k185d agoMedacta International S.A. — MSS - Monobloc stem (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k184d agoOrthosoft Inc. (d/b/a) Zimmer CAS — Signature™ ONE System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k184d agoSpinal Elements, Inc. — Luna® Ti Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k184d agoBard Peripheral Vascular, Inc. — UltraScore™ Focused Force PTA Balloon (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k184d agoZimmer, Inc. — G7® Revision Acetabular System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k184d agoYadu Medical (Henan) Co., Ltd. — Henan Yadu Level 4 Surgical Gowns (Reinforced) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k184d agoEvolution Spine — E3D™-C Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k183d agoEncora, Inc. — Encora X1 (510k cleared)Encore Inc.

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k183d agoDentsply Sirona — Primevision 3D (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k183d agoGe Medical Systems, LLC — SIGNA™ Sprint Select (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k183d agoPenumbra, Inc. — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK (510k cleared)Penumbra Inc

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k183d agoArgon Medical Devices, Inc. — CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoAthelas, Inc. — Athelas Home (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoK2m, Inc. — Q Interbody Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoQuantel Medical — INTEGRE LIO (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoEieling Technology (Shenzhen) Limited — Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoGe Medical Systems, LLC — SIGNA™ Bolt (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoSiemens Healthcare Diagnostics, Inc. — Atellica® IM TSH3-Ultra II (TSH3ULII) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoStryker Leibinger GmbH & Co KG — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoUzinmedicare Co., Ltd. — Spectra S1 Pro; Spectra S2 Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoLive Medica, LLC — LiveMedica Enterprise PACS (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoFujifilm Corporation — Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoSafeBeat Rx, Inc. — SafeBeat Rx App (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoMedian Technologies — Median LCS (internal name) / eyonis LCS (trade name) (1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoPhilips Medizin Systeme Boeblingen GmbH — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoShenzhen Gsd Technology Co., Ltd. — Dermatrix Duo (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoKneevoice, Inc. — Kneevoice Cartilage Evaluation System (750-3600-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoDentsply Sirona, Inc. — Stainless Steel Surgical Kits (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoETHICON, Inc. — MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoInova Diagnostics, Inc. — Aptiva APS IgA Reagent (510k cleared)Co-Diagnostics, Inc.

    Product code: MSV. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoAmferia AB — Amferia Wound Dressing (510k cleared)

    Product code: SHA. Advisory committee: General, Plastic Surgery. Type: Direct

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoAugmented Reality Software S.L. — LAIA XR (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k182d agoBalmoral Medical, LLC — ROSA Knee System with UltraSound Imaging Platform (USIP) (510k cleared)

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

    full page →fda device 510k ↗
    $NNOX1.7300+1.17%
    $XRAY14.13+5.68%
    $ECR
    $DROR0.00500.00%
    $SYK337.43+0.12%
    $DXCM83.02+0.44%
    $PEN324.29-0.11%
    $FRTRY
    $CODX1.51000.00%
    $XRAY14.13+5.68%