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1,631 catalysts · 3,288 8k filing · 2,402 grant · 2,299 approval · 1,631 device 510k · 1,179 device recall · 1,115 device pma

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type: device 510k×from 2025-10-08×clear all
type
  • 8k filing3,288
  • grant2,402
  • approval2,299
  • device 510k1,631
  • device recall1,179
  • device pma1,115
device adverse event
1,000
  • earnings584
  • recall465
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Oct 6, 2025

    45
    ›Oct 8, 2025device 510k310d 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 510k310d 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 510k310d 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 510k310d 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 510k310d 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 510k310d 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 510k310d 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 510k310d agoElekta Solutions AB — ProKnow DS (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2025device 510k310d 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 510k310d agoGenoray Co., Ltd. — GT300; GT300-C (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k309d agoOphtecs Corporation — cleadew GP hydra one (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2025device 510k309d 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 510k309d 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 510k309d 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 510k309d 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 510k309d 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 510k309d 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 510k309d 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 510k309d 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 510k309d 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 510k309d 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 510k309d 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 510k309d 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 510k309d 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 510k309d 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 510k308d 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 510k308d 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 510k308d 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 510k308d 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 510k308d 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 510k308d agoSolventum US, LLC — Tegaderm Post-Op Transparent Antimicrobial Dressing (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k308d agoTHINK Surgical, Inc. — TMINI Miniature Robotic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k308d agoSoclean, Inc. — SoClean 3+ (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k308d agoACON Laboratories, Inc. — On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System (510k cleared)Alcon Laboratories Inc

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k308d agoOsseofuse International, Inc. — HexaPLUS S OneDrill Implant System (510k cleared)ICF International, Inc.

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k308d agoZeta Surgical, Inc. — Zeta Navigation System (ZNS131-US) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k308d agoProcept Biorobotics — HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) (510k cleared)PROCEPT BioRobotics Corp

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k308d agoWinner Medical Co., Ltd. — Collagen Wound Dressing (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k308d agoFoshan Jindi Electric Appliance Co., Ltd. — IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k308d agoCryosurgery, Inc. — Verruca-Freeze H Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k308d agoCanon Medical Systems Corporation — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2025device 510k308d agoNeocis, Inc. — Yomi Robotic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 12, 2025device 510k306d agoInBios International, Inc. — COVID-19 Detect Rapid Self -Test (510k cleared)Synbio International, Inc.

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

    full page →fda device 510k ↗
    ›Oct 12, 2025device 510k306d agoShenzhen Nuon Medical Equipment Co., Ltd. — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 12, 2025device 510k306d agoPollogen, Ltd. — GENEO X ELITE (510k cleared)

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

    full page →fda device 510k ↗

    Week of Oct 13, 2025

    5
    ›Oct 13, 2025device 510k305d agoBone Solutions, Inc. — Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (510k cleared)UL Solutions Inc.

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

    full page →fda device 510k ↗
    ›Oct 14, 2025device 510k
    ← prev
    page 1 of 33
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    304d ago
    Responsive Arthroscopy, LLC — Mini Superhawk Suture Anchor System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 14, 2025device 510k304d agoDawell Medical, LLC — Lithoblast Single Use Holmium Laser Fibers (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 14, 2025device 510k304d agoAsset Medikal — FlowArt® Vial Access Device Vented (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 14, 2025device 510k304d agoShenzhen Qiaochengli Technology Co., Ltd. — IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S) (510k cleared)

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

    full page →fda device 510k ↗
    $ALGN
    $IOBTQ
    $IART18.24+4.95%
    $BSX51.69+0.53%
    $BETA16.10+2.09%
    $KIDS
    $NHNKF
    $SIBN13.41+15.55%
    $FMS23.63-0.38%
    $ICFI89.28-0.33%
    $PRCT
    $SYIN
    $ULS