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5,000 catalysts · 18,987 approval · 5,256 phase readout · 5,000 device 510k · 4,728 grant · 2,539 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: 38 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 16 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 1 catalyst2026-08-11: 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 readout5,256
  • device 510k5,000
  • grant4,728
  • 8k filing2,539
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa319
  • therapy area

    no tagged catalysts yet

    Week of Jun 16, 2025

    26
    ›Jun 20, 2025device 510k406d agoFlosonics Medical — FloPatch FP120 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoAsahi Intecc Co., Ltd. — Branchor X Balloon Guide Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoAcera Surgical, Inc. — Restrata Soft Tissue Reinforcement (STR) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoThermo Fisher Scientific — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoBecton Dickinson — BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoPathpresenter Corporation — PathPresenter Clinical Viewer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoPolynovo Biomaterials Pty, Ltd. — NovoSorb BTM (510k cleared)

    Product code: QSZ. Advisory committee: Unknown. Type: Special

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoErbe Elektromedizin GmbH — HybridAPC probe (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoClaronav — Navient Image Guided Navigation System (ENT) (955-NC-NC) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoOvigenex, LLC — CollOvine™ Wound Dressing (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoHadleigh Health Technologies — Celsi Warmer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoEko.Ai Pte Ltd. D/B/A Us2.Ai — Us2.ca (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoYangzhou Fartley Medical Instrument Technology Co., Ltd. — Disposable Endoscopy Valve Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoMicroaire Surgical Instruments, LLC — PAL Sterilization Case (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoShenzhen Medke Technology Co., Ltd. — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoShenzhen Sunsred Technology Co.,Ltd — LED Facial Mask (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoSpident Co., Ltd. — EsCem RMGI (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoCanon Medical Systems Corporation — CT Scanner TSX-501R/1 V11.1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoAsahi Intecc Co., Ltd. — FUBUKI XF-R Neurovascular Long Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoHcmed Innovations Co., Ltd. — AdheResp Smart Breath-actuated Mesh Nebulizer (510k cleared)GI Innovation Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoMedtronic, Inc. — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoAbbott Laboratories — Alinity i Rubella IgG (510k cleared)ABBOTT LABORATORIES

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoJinhua Qidian Vehicle Co., Ltd. — ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM Thyroglobulin (Tg) (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoWright Medical Technology, Inc. (Stryker) — Incompass Total Ankle System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k406d agoFoshan Guangyu Weilai Medical Equipment Co., Ltd. — LED LIGHT MASK (A093) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jun 23, 2025

    24
    ›Jun 23, 2025device 510k403d agoRizhao Huge Biomaterials Company, Ltd. — TempFIT Temporary Crown and Bridge Resin (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k
    ← prev
    page 49 of 100
    next →
    403d ago
    Idmed — WiTOF (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k403d agoApple, Inc. — Digital Prism Correction Feature (DPCF) (510k cleared)Apple Inc.

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k403d agoVipamat Sarl — Hippocampe Marathon and Trail (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k403d agoOpxion Technology, Inc. — OPXION Optical Skin Viewer (OPXSV1-01F) (510k cleared)WM TECHNOLOGY, INC.

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k403d agoOlympus Medical Systems Corp. — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k403d agoLiofilchem, Inc. — Ceftobiprole BPR 5 µg Disc (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k403d agoBrainlab AG — Cranial 4Pi Immobilization (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k403d agoShenzhen AOJ Medical Technology Co., Ltd. — Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 24, 2025device 510k402d agoProsidyan, Inc. — GPS Advanced; GPS Advanced Cannula (510k cleared)

    Product code: FMF. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Jun 24, 2025device 510k402d agoPro Surgical, Inc. — ProAM ALIF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 24, 2025device 510k402d agoPhilips Image Guided Therapy Devices — Bridge Plus Occlusion Balloon (590-002) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 24, 2025device 510k402d agoHypervision Surgical — HyperSnap Surgical System (HSS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 24, 2025device 510k402d agoImagine Milling Technologies, LLC — MIST IC (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 24, 2025device 510k402d agoOrthoPediatrics Corp. — PediFlex™ Flexible Nail System (510k cleared)ORTHOPEDIATRICS CORP

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

    full page →fda device 510k ↗
    ›Jun 24, 2025device 510k402d agoSpectrum Medical S.R.L. — Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoCg Medtech Co., Ltd. — ANAX™ OCT Spinal System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoPrismatik Dentalcraft, Inc. — Flexible Partial Resin (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoS&G Biotech, Inc. — EGIS Biliary Double Bare Stent (BDB080405) (510k cleared)IO Biotech, Inc.

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoSysmex America, Inc. — Sysmex XR-Series (XR-20) Automated Hematology Analyzer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoSmith & Nephew, Inc. — BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoExpanding Innovations, Inc. — X-PAC® LLIF Expandable Lateral Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k401d agoEnraf-Nonius, B.V. — Curapuls 670 (510k cleared)

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

    full page →fda device 510k ↗
    $ABT105.37-2.44%
    $FRTRY
    $FRTRY
    $TMO447.81+1.31%
    $MDT87.54+0.76%
    $BDX164.75-2.17%
    $AAPL298.01+0.70%
    $SNN30.25+5.29%
    $KIDS
    $MAPS0.3500+2.94%
    $IOBTQ