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calendar

2,834 catalysts · 4,728 grant · 3,350 8k filing · 2,834 device 510k · 2,727 approval · 2,000 device recall · 1,989 device pma

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type: device 510k×from 2025-05-29×clear all
type
  • grant4,728
  • 8k filing3,350
  • device 510k2,834
  • approval2,727
  • device recall2,000
  • device pma1,989
device adverse event
1,000
  • recall693
  • earnings584
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of May 26, 2025

    49
    ›May 29, 2025device 510k444d agoShenzhen Astec Technology Co., Ltd. — TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoBaylis Medical Company, Inc. — VersaCross Connect™ Transseptal Dilator (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoReflow Medical, Inc. — Spur Peripheral Retrievable Stent System (510k cleared)

    Product code: SEU. Advisory committee: Cardiovascular. Type: Direct

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoMedtronic Navigation — Visualase V2 MRI-guided Laser Ablation System (9736422) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoOsteonic Co., Ltd. — SIGNEX (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoTerumo Europe N.V. — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoShanghai AnQing Medical Instrument Co., Ltd. — Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US (510k cleared)

    Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoYueying Medical Instruments (Langfang) Co., Ltd. — Dental Barrier and Sleeves (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoPiccolo Medical, Inc. — PM2+ System and SmartPICC Stylet (510k cleared)Picard Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Voluson™ Performance 16; Voluson™ Performance 18 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoCochlear — Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand (510k cleared)

    Product code: LXB. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoEpic Medical Pte. , Ltd. — ProSeal™ Bag Spike with Additive Port (423370ST, 423370) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoNeurent Medical , Ltd. — NEUROMARK System (NMK00301) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoKuraray Noritake Dental, Inc. — CERABIEN MiLai (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoMasimo Corporation — Radius VSM and Accessories (510k cleared)MASIMO CORP

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoRemex Medical Corp. — Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II (510k cleared)Medicale Corp.

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoGerium Medical, Ltd. — BiliWrap (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k444d agoArthrex, Inc. — SuturePatch Tissue Reinforcement (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoMatelaser, Inc. — MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — TE Air Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoShenzhen TPH Technology Co., Ltd. — Wearable Breast Pump (Model S21) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoOsang, LLC — OHC COVID-19 Antigen Self Test (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoNingbo Youhe Electrical Appliance Technology Co., Ltd. — Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoMindset Medical, Inc. — Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) (510k cleared)Outset Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoThi Total Healthcare Innovation GmbH — ViVi® Toga Premium (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoXbody Hungary Kft. — XBody Go USA, XBody Pro USA (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoSorin Group Italia S.R.L. — VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoJeil Medical Corporation — ARIX Pectus Bar System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoAmber Implants — VCFix Spinal System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoOwens & Minor (O&M) Halyard, Inc. — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce (510k cleared)

    Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Abbreviated

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoFresenius Medical Care Renal Therapies Group, LLC — 5008X Hemodialysis System (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoBonraybio Co., Ltd. — LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer (510k cleared)

    Product code: POV. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoShenzhen TPH Technology Co., Ltd. — Motif Aura Glow breast pump (Model Motif Aura Glow) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoFertipro NV — FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — KALA Red Light Face Mask (KALA-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoAlton (Shanghai) Medical Instruments Co., Ltd. — Endoscopic Distal Attachment (AF-D series) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoClairity, Inc. — Allix5 (510k cleared)

    Product code: SEZ. Advisory committee: Radiology. Type: Direct

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoSpident Co., Ltd. — EsFlow PLUS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoMaquet Cardiovascular, LLC — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoTheramicro — TekBrace Solo Soft Tissue Reinforcement Device (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoBalt USA, LLC — Prestige Coil System (Prestige Packing Line Extension) (510k cleared)Bayer USA LLC

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoAudax D.O.O. — AudaxCeph Cephalogram Analysis Software (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoVapocoolshot, Inc. — DentalJect (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoHyperfine, Inc. — Swoop® Portable MR Imaging® System (V2) (510k cleared)Hyperfine, Inc.

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoTalladium España, SL — Dynamic TiBase (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoOlympus Medical Systems Corporation — Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) (510k cleared)

    Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›May 30, 2025device 510k443d agoRoche Molecular Systems, Inc. — Opulus™ Lymphoma Precision (510k cleared)

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

    full page →fda device 510k ↗
    ›May 31, 2025device 510k442d agoLimFlow, Inc. — LimFlow ARC (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jun 2, 2025

    1
    ›Jun 2, 2025device 510k440d agoScience & Bio Materials (S.B.M.) Sas — PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $FRTRY
    $FRTRY
    $MCLE
    $MASI
    $PMI0.1821-4.66%
    $HYPR
    $FRTRY
    $OM4.5200-1.09%
    $FMS23.77+0.59%