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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,970 phase readout · 4,728 grant · 2,443 8k filing · 2,000 device pma

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2026-07-27: 31 catalysts2026-07-28: 4 catalysts2026-07-29: 12 catalysts2026-07-30: 12 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 12 catalysts2026-08-05: 14 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: 0 catalysts2026-08-14: 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: 0 catalysts2026-10-22: 1 catalyst2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,970
  • grant4,728
  • 8k filing2,443
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings296
  • therapy area

    no tagged catalysts yet

    Week of Mar 31, 2025

    38
    ›Apr 2, 2025device 510k482d agoIcu Medical, Inc. — LifeShield Infusion Safety Software Suite (510k cleared)ICU MEDICAL INC/DE

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k482d agoNvision Biomedical Technologies, Inc. — SnapHammer Hammertoe Correction System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k482d agoAsahi Intecc Co., Ltd. — SION blue PLUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k482d agoShenzhen TPH Technology Co., Ltd. — eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060; (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k481d agoSiemens Healthcare GmbH — syngo Dynamics (Version VA41D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k481d agoFresenius Medical Care Renal Therapies Group, LLC — stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k481d agoCarbon (Shenzhen) Medical Device Co., Ltd. — Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k481d agoShina Med Corporation — SureFine Pen Needle (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k481d agoBeaver-Visitec International, Inc. — Leos Laser and Endoscopy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k481d agoOSSIO , Ltd. — OSSIOfiber® Suture Anchor 2.5-3.5 mm (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k481d agoXsto Co., Ltd. — Powered wheelchair (mobility robot) (M4, M4U) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k481d agoStaclear, Inc. — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k481d agoSpine Wave, Inc. — Salvo® Robotic Navigation Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k481d agoMasimo Corporation — Masimo W1 (510k cleared)MASIMO CORP

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoBiotronik, Inc. — Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoNingbo Dechang Electrical Machinery Made Co.,Ltd — LED Light Therapy Mask (RT01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoPhilips Medical Systems Nederland B.V. — Philips VSC-MEDlib (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoABBOTT MEDICAL — JETi Hydrodynamic Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoDeski — HeartFocus (V.1.1.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoTerumo Europe N.V. — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoHighridge Medical, LLC — Virage® OCT Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoWuhan Pioon Technology Co., Ltd. — Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoTurbett Surgical — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Viral Transport Medium (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoPrapela, Inc. — Prapela SVS hospital bassinet pad (model P01) (510k cleared)

    Product code: QVY. Advisory committee: General Hospital. Type: Direct

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoApex BioTechnology Corp. — UASure II Blood Uric Acid Monitoring System (510k cleared)PDS Biotechnology Corp

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoDraegerwerk AG & CO Kgaa — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoRaySearch Laboratories AB (PUBL) — RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoWhoop., Inc. — WHOOP ECG (electrocardiogram) Feature (1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoSpectrum Spine, Inc. — Spectrum Spine Lumbar Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoFoqus Technologies, Inc. — DeepFoqus (DeepFoqus-Accelerate) (510k cleared)FOXO TECHNOLOGIES INC.

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoDegen Medical — DeGen Medical Patient Specific Implant (PSI) System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoFresenius Medical Care Renal Therapies Group, LLC — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d ago3Shape TRIOS A/S — TRIOS Ready Tip (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoOculogica, Inc. — EyeBOX EBX-4.1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoQfr Solutions BV — QFR (3.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k480d agoSeigla Medical, Inc. — LiquID .051 LP Guide Catheter Extension (510k cleared)

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

    full page →fda device 510k ↗

    Week of Apr 7, 2025

    12
    ›Apr 7, 2025device 510k477d agoConmed Corporation — BioBrace ® RC Delivery System (510k cleared)CONMED Corp

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

    full page →fda device 510k ↗
    ›Apr 7, 2025device 510k
    ← prev
    page 34 of 100
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    477d ago
    Bomtech Electronics Co., Ltd. — E-PEN (E-PEN) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2025device 510k477d agoAPK Technology Co., Ltd. — Ultraviolet Phototherapy Device (510k cleared)Lens Technology Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Apr 7, 2025device 510k477d agoShenzhen Borria Technology Co., Ltd. — LED Therapy Mask (MN1, M226) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Apr 7, 2025device 510k477d agoBiocomposites, Ltd. — NanoBone® SBX Putty ; NanoBone® QD (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2025device 510k477d agoTyto Care , Ltd. — Tyto Insights for Rhonchi Detection (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2025device 510k477d agoGuangzhou Pinzhi Medical Technology Co., Ltd. — Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k476d agoBunkerHill Health — BunkerHill BMD (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k476d agoShenzhen Nuon Medical Equipment Co., Ltd. — Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k476d agoIcat Solutions, Ltd. — Horos Mobile (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k476d agoTriMed, Inc. — TriMed Fusion Cup System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k476d agoHangzhou Sightnovo Medical Technology Co., Ltd. — Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) (510k cleared)

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

    full page →fda device 510k ↗
    $ICUI161.46+2.55%
    $FRTRY
    $MASI
    $FMS24.87+1.14%
    $FOXO
    $PDSB0.6927+1.66%
    $FMS24.87+1.14%
    $CNMD32.58+1.46%
    $LNTCY
    $FRTRY