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5,000 catalysts · 18,987 approval · 5,811 phase readout · 5,000 device 510k · 4,728 grant · 2,984 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,811
  • device 510k5,000
  • grant4,728
  • 8k filing2,984
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings516
  • therapy area

    no tagged catalysts yet

    Week of Mar 9, 2026

    50
    ›Mar 11, 2026device 510k150d agoHuizhou Foryou Medical Co., Ltd. — LUOFUCON® Antimicrobial Wound Gel (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2026device 510k150d agoDepuy Ireland UC — INHANCE™ Reverse Shoulder System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2026device 510k150d agoShenzhen Chuangtong Yigou Technology Co., Ltd. — Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2026device 510k150d agoRiverpoint Medical, LLC — Strut Suture; No-Tie Button (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2026device 510k150d agoKulzer, LLC — Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2026device 510k150d agoNewclip Technics — Xpert Hand (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2026device 510k150d agoLivaNova USA, Inc. — Venous Return Cannulae (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2026device 510k150d agoIntuitive Surgical, Inc. — da Vinci Force Feedback Instruments (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Mar 11, 2026device 510k150d agoCarestream Health — Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2026device 510k150d agoCAO Group, Inc. — Picasso Pro Diode Laser (002-00460) (510k cleared)CAVA GROUP, INC.

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoHsiner Co., Ltd. — VPAP Pediatric Face Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoInvera Medical — InVera Infusion Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoBionit Labs Srl — Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoFree Flow Medical, Inc. — LungFlow Basket Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoGuangzhou Ajax Medical Equipment Co., Ltd. — Dental X-RAY Unit (AJX200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoHR Healthcare — Liv Pre-lubricated Intermittent Catheter (510k cleared)HCA Healthcare, Inc.

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoA Cute Baby, Inc. — Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoDigestaid - Artificial Intelligence Development SA — Deep Capsule® (Deep Capsule US) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoProdeon Medical, Inc. — Urocross Expander System (Model Numbers ES2018 and ES3025) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoStryker Leibinger GmbH & Co KG — MEDPOR Customized Implant Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoAIRICU, Inc. — Medical Mesh Nebulizer (AirICU Max+) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoSpectrum Medical S.R.L. — Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoNanjing Mijo Technology Co., Ltd. — Power Mobility Scooter (MJMA01, MJMA02) (510k cleared)Nanjing Miracle Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoSpectrum Medical S.R.L. — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoTermosalud S.L. — Zionic Pro Max (EMS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoZimmer, Inc. — Affixus Retrograde Femoral Nailing System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoMaterialise NV — Mimics Thoracic Planner (510k cleared)MATERIALISE NV

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoGenadyne Biotechnologies, Inc. — Genadyne ASTRA NPWT (510k cleared)POP Biotechnologies Inc

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoSignature Orthopaedics Pty, Ltd. — Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (510k cleared)

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoMedtronic Minimed, Inc. — MiniMed Flex pump (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoTyto Care , Ltd. — Tyto Stethoscope (G3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoTrax Surgical, Inc. — Trax EX Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoAllevion Medical, LLC — VantageTM Lumbar Decompression Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoTaurus Endoscopy — Taurus Clip (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoImplantcast GmbH — implaFit® short stems (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k149d agoRapid Medical , Ltd. — Tigertriever 25 Revascularization Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k148d agoMars Bioimaging , Ltd. — Extremity CT Imaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k148d agoAspect Imaging, Ltd. — Embrace Neonatal MRI System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k148d agoBecton, Dickinson and Company — BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k148d agoBeijing Infervision Healthcare Medical Technology Co., Ltd. — InferCare RECIST (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k148d agoCortex, Inc. — OptiMap Catheter - 50mm (OPTI-CATH2-50) (510k cleared)Corteva, Inc.

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k148d agoCanon Medical Systems Corporation — Aquilion ServeSP (TSX-307B) V2.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k148d agoOrthocon, Inc. — Permatage Flowable, Settable Bone Paste (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k148d agoABBOTT MEDICAL — Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k148d agoGIE Medical — BARE Wireguided Balloon Dilation Catheter (1235) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k148d agoIasis Technologies — IASIS i2 Relaxation Neurofeedback System (510k cleared)Niu Technologies

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k148d agoOculus Optikgeräte GmbH — Pentacam® Cornea OCT (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k148d agoMedtronic Navigation, Inc. — Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k148d agoGood Methods Global, Inc. — Aeka Imaging (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k148d agoBeckman Coulter, Inc. — Access anti-HBc IgM (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $MTLS6.5600-1.06%
    $ISRG378.81+1.36%
    $NIU2.4600+0.41%
    $CTVA75.15+0.93%
    $HCA413.36+1.09%
    $BDX176.86-0.12%
    $CAVA76.38+3.75%