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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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2026-07-27: 0 catalysts2026-07-28: 0 catalysts2026-07-29: 0 catalysts2026-07-30: 0 catalysts2026-07-31: 0 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 17 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 2 catalysts2026-08-11: 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 readout5,347
  • 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

    50
    ›Sep 30, 2025device 510k306d agoAstrasono Technology Co., Ltd. — Astrasono A3Pro Bladder Scanner (A3Pro) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2025device 510k306d agoWright Medical Technology, Inc. (Stryker Corporation) — Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2025device 510k306d agoFehling Instruments GmbH — Biopsy Forceps (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2025device 510k306d agoParagon 28, Inc. — External Fixation Mini Rail System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2025device 510k306d agoCenters for Disease Control and Prevention — Francisella tularensis Real-time PCR assay (510k cleared)Hubei Provincial Center for Disease Control and Prevention

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

    full page →fda device 510k ↗
    ›Sep 30, 2025device 510k306d agoDistalmotion SA — Dexter L6 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2025device 510k306d agoArthrex, Inc. — Arthrex SpeedFLEX™ Implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2025device 510k306d agoShanghai Draeger Medical Instrument Co., Ltd. — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2025device 510k306d agoTigerconnect — TigerConnect Alarm Management (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2025device 510k305d agoNew Deantronics Taiwan , Ltd. — E Blator (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2025device 510k305d agoNu-Rise, SA — PRO-DOSE System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2025device 510k305d agoVena Medical Holdings Corp — Vena MicroAngioscope™ System (510k cleared)SELECT MEDICAL HOLDINGS CORP

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

    full page →fda device 510k ↗
    ›Oct 1, 2025device 510k305d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL, (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2025device 510k305d agoMerchsource, LLC — Light Therapy Decollete Mask (1019135) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2025device 510k305d agoVisby Medical, Inc. — Visby Medical Men's Sexual Health Test (510k cleared)Vivani Medical, Inc.

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

    full page →fda device 510k ↗
    ›Oct 1, 2025device 510k305d agoShenzhen Ulike Smart Electronics Co., Ltd. — Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2025device 510k305d agoHebei Newangie Technology Co., Ltd. — Picosecond laser device (BMPS4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2025device 510k305d agoWuxi Hisky Medical Technologies Co., Ltd. — Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2025device 510k305d agoNewclip Technics — Newclip Patient-matched instrumentation non sterile PSI (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k304d 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 510k304d 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 510k304d 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 510k304d 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 510k304d 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 510k304d 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 510k304d agoThirona BV — LungQ 4 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k304d 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 510k304d 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 510k304d agoExemplar Medical, LLC — BreatheBand® (Model 1000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2025device 510k304d 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 510k304d 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 510k304d 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 510k304d 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 510k303d 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 510k303d 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 510k303d 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 510k303d 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 510k303d 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 510k303d 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 510k303d agoBunkerHill Health — Bunkerhill MAC (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k303d 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 510k303d 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 510k303d agoHealthhub — HPACS (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k303d 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 510k303d agoABBOTT MEDICAL — Amplatzer Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k303d 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 510k303d 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 510k303d agoAugmedics, Ltd. — xvision Spine system (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2025device 510k303d 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 510k303d 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 ↗
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    $FRTRY
    $AORT
    $VANI1.6000+18.52%
    $PRKA
    $SEM16.450.00%
    $FRTRY
    $ISRG353.33+0.10%
    $ICCM0.2280+3.64%