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calendar

1,681 catalysts · 3,189 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 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: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 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: 2 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: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device 510k×from 2025-10-02×clear all
type
  • 8k filing3,189
  • grant2,402
  • approval2,350
  • device 510k1,681
  • device recall1,204
  • device pma1,151
device adverse event
1,000
  • earnings584
  • recall465
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Sep 29, 2025

    33
    ›Oct 2, 2025device 510k315d agoShenzhen Enmind Technology Co., Ltd. — IPL Hair Removal Device (IPL-001, IPL-002) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k315d agoNingbo Tianyi Medical Appliance Co., Ltd. — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k315d agoGC America, Inc. — G-Bond Universal (510k cleared)PARKS AMERICA, INC

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k315d agoPhilips Medical Systems Nederland B.V. — Philips IntelliSpace Cardiovascular (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k315d agoShenzhen Finicare Co., Ltd. — Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k315d agoSimergent, LLC — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k315d agoThirona BV — LungQ 4 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k315d agoLiofilchem s.r.l. — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (510k cleared)Bristol-Myers Squibb Co

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k315d agoArtivion, Inc. — CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) (510k cleared)ARTIVION, INC.

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k315d agoExemplar Medical, LLC — BreatheBand® (Model 1000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k315d agoShenzhen Sophway Technology Co., Ltd. — 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k315d agoIngeniars S.R.L. — EasyTeleMed (2.0.2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k315d agoApplied Medical Resources Corp. — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (510k cleared)PATH

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k315d agoOrthonovis, Inc. — Cannulated Screw and Kirschner (K wire) System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoShanghai AnQing Medical Instrument Co., Ltd. — Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoNingbo Shenyu Medical Equipment Co.,Ltd — Manual Wheelchair (SYIV100A008) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoMagentiq Eye, Ltd. — MAGENTIQ-COLO (ME-APDS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoHollister Incorporated — Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoRevolve Surgical, Inc. — Revolve Surgical System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoSenbitec Co., Ltd. — HESTIA (L200-A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoBunkerHill Health — Bunkerhill MAC (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoAlleva Medical Devices — extriCARE® 1000 Negative Pressure Wound Therapy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoJeisys Medical Incorporated — TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoHealthhub — HPACS (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoABBOTT MEDICAL — Amplatzer Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoInternacional Farmacéutica S.A DE C.V — PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoDongguan Yiyao Science & Technology Development Co., Ltd. — Anti Snore Mouthpiece (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoAugmedics, Ltd. — xvision Spine system (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoIcecure Medical — ProSense™ System (510k cleared)IceCure Medical Ltd.

    Product code: QXW. Advisory committee: General, Plastic Surgery. Type: Direct

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d agoTosoh Bioscience, Inc. — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (510k cleared)BJ Bioscience Inc

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k314d 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 510k314d 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

    17
    ›Oct 6, 2025device 510k311d 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 1 of 34
    next →
    311d 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 510k311d agoColoplast Corp. — Heylo™ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 6, 2025device 510k311d 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 510k311d 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 510k311d agoDeep Breathe, Inc. — BlineSlide (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 6, 2025device 510k311d 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 510k310d agoDamae Medical — deepLive (OSP12 + DMS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2025device 510k310d 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 510k310d 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 510k310d 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 510k310d 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 510k310d 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 510k310d 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 510k310d agoMetamorphosis GmbH — AIAS Cephalon (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2025device 510k310d 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 510k310d 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 ↗
    $FRTRY
    $ISRG401.27+0.01%
    $ICCM0.2280+3.64%
    $AORT
    $FRTRY
    $PRKA
    $SNN29.84-0.57%
    $MMSI91.20+0.10%