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2,933 catalysts · 4,728 grant · 3,603 8k filing · 2,933 device 510k · 2,761 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2025-05-19×clear all
type
  • grant4,728
  • 8k filing3,603
  • device 510k2,933
  • approval2,761
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall723
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of May 19, 2025

    50
    ›May 19, 2025device 510k469d agoRowpar Pharmaceuticals, Inc. — CloSYS® Dry Mouth Sensitive Mouth Rinse (510k cleared)RVL Pharmaceuticals Inc

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k469d agoSplintek, Inc. — SleepRight Snore Aid (510k cleared)

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k469d agoRoute 92 Medical, Inc. — Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (510k cleared)

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k469d agoNanjing Perlove Medical Equipment Co., Ltd. — Diagnostic X-ray System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k469d agoGigaalaser Company , Ltd. — Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k469d agoDoc Brands, Inc. — Dentemp Pro-Comfort Dental Guard (510k cleared)BT Brands, Inc.

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k469d agoBecton, Dickinson and Company — BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k469d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost (510k cleared)

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k469d agoVision Rt, Ltd. — MapRT (510k cleared)Rail Vision Ltd.

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k469d agoZhengzhou PZ Laser Slim Technology Co., Ltd. — Muscle Stimulator Device (PZ-100) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k469d agoResmed Pty , Ltd. — AirFit F20 Mask System; AirFit F20 NM Mask System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k469d agoRestor3D — restor3d Reverse Total Shoulder Arthroplasty System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 20, 2025device 510k468d agoFlexicare Medical Limited. — ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 20, 2025device 510k468d agoAidite (Qinhuangdao) Technology Co., Ltd. — Biomic Color Opaque (510k cleared)

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

    full page →fda device 510k ↗
    ›May 20, 2025device 510k468d agoBreas Medical AB — EveryWare (510k cleared)

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

    full page →fda device 510k ↗
    ›May 20, 2025device 510k468d agoExpanding Innovations, Inc. — X-PAC® N-GAGE™ Lumbar Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 20, 2025device 510k468d agoABBOTT MEDICAL — ViewFlex™ X ICE Catheter, Sensor Enabled™ (510k cleared)

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

    full page →fda device 510k ↗
    ›May 20, 2025device 510k468d agoFujifilm Corporation — SCENARIA View Phase 5.0 (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›May 20, 2025device 510k468d agoMet One Technologies, LLC — Sovereign Posterior Cervical System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 20, 2025device 510k468d agoMedtronic, Inc. — VitalFlow Console (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›May 20, 2025device 510k468d agoKeystone Industries — FP3D (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoShanghai United Imaging Healthcare Co., Ltd. — uMR Omega (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoMem Dental Technology Co., Ltd. — MEM Clear Aligner System (510k cleared)Meiwu Technology Co Ltd

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoFujifilm Corporation — Synapse 3D Base Tools (V7.0) (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoRay Co., Ltd. — SMARTDent (510k cleared)Ray Therapeutics Inc

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoIntegrity Implants Inc. Dba Accelus — FlareHawk Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoSpinal Elements, Inc. — The Karma® Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoVoco GmbH — GrandioSO Unlimited (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoStryker Endoscopy — Stryker AlphaVent™ Knotless SP Biocomposite Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoHyperfine, Inc. — Swoop® Portable MR Imaging® System (510k cleared)Hyperfine, Inc.

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoPrintbio, Inc. — 3DMatrix DynaFlex (DynaFlex) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoHjy Smart Medical Device Co., Ltd. — HJY VisualNext 3D Endoscopic Vision System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoTandem Diabetes Care, Inc. — Control-IQ+ technology (510k cleared)TANDEM DIABETES CARE INC

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoFinemedix Co., Ltd. — ClearHemograsper (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoInVision Medical Technology Corporation — InVision Precision Cardiac Amyloid (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoAnx Robotica Corporation — MotiliCap GI Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k467d agoAlma Lasers, Inc. — The Alma Hybrid Laser System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k466d agoBasic Medical Technology, Inc. — Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k466d agoHua Yue Medical Technology Co., Ltd. — Harioculture TL-16 Time-lapse Incubator (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k466d agoUrotronic, Inc. — Optilume® High Pressure Urological Balloon Dilation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k466d agoClinical Innovations, LLC — Koala Intrauterine Pressure Catheter (IPC-5000E) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k466d agoTriMed, Inc. — TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k466d agoOrtho Development Corp. — Trivicta® Hip Stem (510k cleared)DeFi Development Corp.

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k466d agoCryoconcepts LP — Skin Clinic Freeze Point for Warts and Skin Tags (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k466d agoRandox Laboratories, Ltd. — ConcizuTrace™ ELISA (510k cleared)Rafa Laboratories Co Ltd

    Product code: SES. Advisory committee: Hematology. Type: Direct

    full page →fda device 510k ↗
    ›May 22, 2025device 510k466d agoArthrex, Inc. — Arthrex Spine Compression FT Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k466d agoOvesco Endoscopy AG — ArgoCap (200.52) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k466d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k466d agoTerrats Medical SL — DESS Dental Smart Solutions (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $WNW
    $MDT91.23+1.40%
    $RVSN4.4000-4.56%
    $BTBD
    $TNDM21.43+0.14%
    $MDCE0.00020.00%
    $HYPR
    $DFUKF
    $BDX189.52+0.74%