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calendar

2,859 catalysts · 4,728 grant · 3,603 8k filing · 2,859 device 510k · 2,736 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2025-05-27×clear all
type
  • grant4,728
  • 8k filing3,603
  • device 510k2,859
  • approval2,736
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall719
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of May 26, 2025

    50
    ›May 27, 2025device 510k461d agoPuritan Medical Products, LLC — Puritan PurSafe Plus Collection and Transport System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoDistalmotion SA — Dexter L6 System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoPreventamed Technologies, Inc. Dba Surfacide Manufacturing — Helios+ UV-C System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoNingbo Baichen Medical Devices Co., Ltd. — Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoOSSIO , Ltd. — OSSIOfiber® Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoMedicalgorithmics S.A. — DeepRhythmAI (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoJjgc Indústria E Comércia DE Materiais Dentários S.A. — Neodent Implant System - Custom Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoTheodent, LLC — Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoShofu Dental Corporation — BEAUTIFIL II (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoOlympus Medical Systems Corp. — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoMipont Medical Equipment Co., Ltd. — Integral Dental Units (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoABBOTT MEDICAL — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoResmed Corp — myAir (510k cleared)RESMED INC

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoLivermoretech, Inc. — Europa (Alternative: AiRTouch) portable X-ray system (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoPacific Care Limited — Disposable Prophy Angle (510k cleared)

    Product code: EGS. Advisory committee: Dental. Type: Abbreviated

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoShenzhen Insighters Medical Technology Co., Ltd. — Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1. (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoImperative Care, Inc. — Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoTermosalud S.L. — Zionic Pro Max (Radiofrequency) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoBoston Scientific Corporation — OptiMap™ System (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoTaiwan Medical Imaging Co., Ltd. — TAIMedImg DeepMets (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoSurGenTec, LLC — OsteoFlo HydroFiber (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoOpcom Medical, Inc. — Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoIradimed Corporation — MRidium 3870 MRI Infusion Pump System (3870) (510k cleared)IRADIMED CORP

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoIschemaview, Inc. — Rapid MLS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoSmart Soft Healthcare AD — CoLumboX (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k459d 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 510k459d 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 510k459d 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 510k459d 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 510k459d agoOsteonic Co., Ltd. — SIGNEX (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k459d 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 510k459d 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 510k459d 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 510k459d 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 510k459d 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 510k459d 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 510k459d 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 510k459d 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 510k459d agoKuraray Noritake Dental, Inc. — CERABIEN MiLai (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k459d 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 510k459d 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 510k459d agoGerium Medical, Ltd. — BiliWrap (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k459d 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 510k458d 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 510k458d 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 510k458d 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 510k458d 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 510k458d 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 510k458d 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 510k458d 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 ↗
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    $OM4.5200-1.09%
    $MASI
    $BSX46.84+0.36%
    $FRTRY
    $PMI0.1821-4.66%
    $IRMD
    $MCLE
    $RMD220.38+5.13%
    $FRTRY