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820 catalysts · 3,350 8k filing · 2,088 grant · 1,110 approval · 1,000 device adverse event · 820 device 510k · 587 device pma

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type: device 510k×from 2026-01-12×clear all
type
  • 8k filing3,350
  • grant2,088
  • approval1,110
  • device adverse event1,000
  • device 510k820
  • device pma587
earnings
584
  • device recall307
  • recall215
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jan 12, 2026

    50
    ›Jan 12, 2026device 510k216d agoArthrex, Inc. — Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k216d agoPromethean Restorative, LLC — DYNAMIS™ Navigation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k216d agoFoshan Topmed Dental Co., Ltd. — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k216d agoEmpower Ride, LLC — EmpowerRide NAVIGATOR (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k216d agoFoshan Topmed Dental Co., Ltd. — High speed air turbine handpiece (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k216d agoBeatles Medical Supplies (Xiantao) Co., Ltd. — Disposable Surgical Face Mask (3P00B, C2900) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k216d agoDentalez, Inc., Stardental Division — Star E900 Electric System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k216d agoShenzhen Hingmed Medical Instrument Co., Ltd. — Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k216d agoSioxmed, LLC — SBC1 Cream (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k216d agoBoston Aesthetics, Inc. — Boston iFace (Boston iFace) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k216d agoPrecision AI Pty, Ltd. — Precision AI Surgical Planning System (PAI-SPS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k216d agoMediclus Co., Ltd. — Any-Paste (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k216d agoTheotclab Healthcare B.V. — Dr. Yglo Skin Tag Remover (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k216d agoSonomotion, Inc. — Break Wave (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k215d agoMiach Orthopaedics, Inc. — BEAR® (Bridge-Enhanced ACL Restoration) Implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k215d agoSpinal Resources, Inc. — Swedge™ Pedicle Screw Fixation System Bezier Rod (510k cleared)RGC RESOURCES INC

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k215d agoSpectrum Dynamics Medical, Ltd. — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k215d agoDmp Dental Industry S.A. — Bright Cavity Liner (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k215d agoStryker Endoscopy — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k215d agoKossan International Sdn Bhd — Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k214d agoSync Surgical — Cervical Interbody and VBR Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k214d agoZiehm-Orthoscan, Inc. — Orthoscan TAU MVP Mini C-Arm System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k214d agoMeticuly Co., Ltd. — METICULY Patient-specific titanium mesh implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k214d agoPhilips Medical Systems Nederland B.V. — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k214d agoCardinalhealth — Cardinal Health Nitrile Examination Gloves Extended Cuff (510k cleared)CARDINAL HEALTH INC

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k214d agoBrainlab SE — ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k214d 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 ↗
    ›Jan 14, 2026device 510k214d agoLaboratorios Biogalenic S.A. DE C.V. — Laboratorios Biogalenic Sterile Water for Inhalation, USP (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k214d agoMedtronic, Inc. — Concerto Versa™ Detachable Coil (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k214d agoEntire Medical , Ltd. — ENTire IRE System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoCuriteva, Inc. — Curiteva Porous PEEK Cervical Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoBAAT Medical Products B.V. — SDS Growing Rod (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoFoshan Dahao Medical Technology Co., Ltd. — Electric Wheelchair (DH01168) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoThera B Medical Products — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoSiemens Healthineers AG — BIOGRAPH One (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoDGNCT, LLC — Diagnocat (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoMedtronic, Inc. — Bio-Medicus Life Support Catheter and Introducer (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoSleepnet Corporation — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoPhenox, Ltd. — Esperance pHLO Aspiration System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoInMode , Ltd. — Ignite RF System (510k cleared)InMode Ltd.

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoElekta Solutions AB — EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) (510k cleared)Scilex Holding Co

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoMaxx Orthopedics, Inc. — Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoBridge TO Life, Ltd. — VitaSmart Hypothermic Oxygenated Perfusion System (510k cleared)

    Product code: SGY. Advisory committee: Gastroenterology, Urology. Type: Direct

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoShoulder Innovations, Inc. — N22 EZ Glenosphere (510k cleared)SHOULDER INNOVATIONS, INC.

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoShanghai Bangbang Robotics Co., Ltd. — Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoMedtronic Minimed, Inc. — MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoEncore Medical L.P. — AltiVate Reverse® ADLC Glenosphere (510k cleared)Encore Medical, Inc.

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoTriMed, Inc. — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoInquis Medical — Aventus Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k213d agoNano-Ditech Corporation — Nano-Check Influenza A+B Test (510k cleared)

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

    full page →fda device 510k ↗
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    $MDT91.27+0.76%
    $SCLX8.8000+25.00%
    $INMD
    $RGCO
    $MDT91.27+0.76%
    $CAH235.17+1.70%
    $EMI
    $SI