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calendar

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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type: device 510k×clear all
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  • 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 Sep 29, 2025

    2
    ›Oct 3, 2025device 510k304d agoSmith & Nephew, Inc. — AETOS Shoulder System Stemless Humeral Prosthesis (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k304d agoOlympus Medical Systems Corporation — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Oct 6, 2025

    48
    ›Oct 6, 2025device 510k301d agoPainchek Limited (Ltd.) — PainChek (PainChek Adult) (510k cleared)

    Product code: SGB. Advisory committee: Neurology. Type: Direct

    full page →fda device 510k ↗
    ›Oct 6, 2025device 510k
    ← prev
    page 68 of 100
    next →
    301d ago
    Zhejiang Topwe Tools Manufacturing Co.,Ltd — Wheelchair (N817) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 6, 2025device 510k301d agoColoplast Corp. — Heylo™ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 6, 2025device 510k301d agoNanjing Kangni Smart Technology Co., Ltd. — Folding Mobility Scooter (KD101) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 6, 2025device 510k301d agoRapid Medical , Ltd. — Tigertriever 17 Ultra Revascularization Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 6, 2025device 510k301d agoDeep Breathe, Inc. — BlineSlide (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 6, 2025device 510k301d agoCovidien, LLC — Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2025device 510k300d agoDamae Medical — deepLive (OSP12 + DMS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2025device 510k300d agoAcotec Scientific Co., Ltd. — Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2025device 510k300d agoEminent Spine — Eminent Spine Posterior SI System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2025device 510k300d agoOlympus Medical Systems Corporation — Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2025device 510k300d agoProdeon Medical, Inc. — Prodeon Urethral Sheath System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2025device 510k300d agoOlympus Medical Systems Corporation — Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2025device 510k300d agoXemis Medical Technology (Shenzhen) Co., Ltd. — Ultrasound Therapy Workstation (XMS-UET2) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Oct 7, 2025device 510k300d agoMetamorphosis GmbH — AIAS Cephalon (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2025device 510k300d agoVarian Medical Systems, Inc. — TrueBeam, TrueBeam STX, Edge and VitalBeam (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Oct 7, 2025device 510k300d agoSt. shine Optical Co., Ltd. — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2025device 510k299d agoRoche Diagnostics — Elecsys Phospho-Tau (181P) Plasma (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›Oct 8, 2025device 510k299d agoBellamia Technologies, Inc. — The Botticelli (Model: Athena) (510k cleared)BETA Technologies, Inc.

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

    full page →fda device 510k ↗
    ›Oct 8, 2025device 510k299d agoBecton Dickinson Infusion Therapy Systems, Inc. — BD Saf-T-Intima™ Subcutaneous Catheter System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2025device 510k299d agoExtremity Medical, LLC — MetaFore Small Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2025device 510k299d agoSerpex Medical, Inc. — Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2025device 510k299d agoAbiomed, Inc. — 14Fr Low Profile Introducer Kit (510k cleared)Abion Inc

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

    full page →fda device 510k ↗
    ›Oct 8, 2025device 510k299d agoIntegra LifeSciences Corporation — CUSA® Clarity Ultrasonic Surgical Aspirator System (510k cleared)INTEGRA LIFESCIENCES HOLDINGS CORP

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

    full page →fda device 510k ↗
    ›Oct 8, 2025device 510k299d agoElekta Solutions AB — ProKnow DS (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2025device 510k299d agoClinical Innovations, LLC — Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2025device 510k299d agoGenoray Co., Ltd. — GT300; GT300-C (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoOphtecs Corporation — cleadew GP hydra one (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoAlign Technology, Inc. — Invisalign Specifix Attachment System (510k cleared)ALIGN TECHNOLOGY INC

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoShenzhen Jianchao Intelligent Technology Co., Ltd. — Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoAdvin Biotech, Inc. — VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup (510k cleared)IO Biotech, Inc.

    Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoOrthoPediatrics Corp. — Pediatric Plating Platform I Small-Mini (510k cleared)ORTHOPEDIATRICS CORP

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoHonsun (Nantong) Co., Ltd. — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoBoston Scientific — Orca Air/Water and Suction Valves (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — ORA Method LED Gua Sha (GS-04) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoNihon Kohden Corporation — EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) (510k cleared)Nihon Kohden Corporation/ADR

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoIray Imaging Technology (Haining) Limited — Lux HD 2530 detector (Lux HD 2530) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoHaemoband Surgical, Ltd. — SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoCotton High Tech S.L. — COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS (510k cleared)

    Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Special

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoFresenius Medical Care Renal Therapies Group, LLC — DIASAFEplusUS (F00013010) (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k298d agoSI-BONE, Inc. — iFuse Bedrock Granite Implant System (510k cleared)SI-BONE, Inc.

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k297d agoDev4 — Eleganz IM Threaded Nail System (IM Threaded Nail System) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k297d agoEvoEndo, Inc. — EvoEndo Single-Use Endoscopy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k297d agoDegen Medical — DeGen Medical Latitude-C AM Cervical Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k297d agoGold Standard Diagnostics, LLC — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k297d agoOlympus Medical Systems Corporation — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k297d agoSolventum US, LLC — Tegaderm Post-Op Transparent Antimicrobial Dressing (510k cleared)

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

    full page →fda device 510k ↗
    $SNN30.25+5.29%
    $ALGN
    $IART16.65-2.75%
    $BETA16.10+2.09%
    $KIDS
    $NHNKF
    $BSX46.73+1.59%
    $MMSI85.01+1.99%
    $IOBTQ
    $FMS25.66-0.16%
    $SIBN13.41+15.55%