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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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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 Apr 14, 2025

    10
    ›Apr 18, 2025device 510k466d agoCarrtech Corp — FROG (Filter Removal of Glass) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 18, 2025device 510k466d agoSofwave Medical, Ltd. — SofWave System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 18, 2025device 510k466d agoAllengers Medical Systems Limited — Wireless/ Wired X-Ray Flat Panel Detectors (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 18, 2025device 510k466d agoSEKISUI Diagnostics, LLC — Acucy® Influenza A&B Test with the Acucy® 2 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 18, 2025device 510k466d agoiSMART Developments, Ltd. — handLITE (TN19S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 18, 2025device 510k466d agoZimmer Biomet — Zimmer Biomet Ceramic Heads (22.2mm diameter) (510k cleared)ZIMMER BIOMET HOLDINGS, INC.

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

    full page →fda device 510k ↗
    ›Apr 18, 2025device 510k466d agoTechnoflex Sas. — DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 18, 2025device 510k466d agoLuminex Corporation — LIAISON PLEX Gram-Negative Blood Culture Assay (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 18, 2025device 510k466d agoTamabio — PeriBeam® Pericardial Membrane (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 18, 2025device 510k466d agoSKY Medical, a.s. — Extension Feeding Set with ENFit™ Connectors (510k cleared)

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

    full page →fda device 510k ↗

    Week of Apr 21, 2025

    40
    ›Apr 21, 2025device 510k463d agoEc Certification Service GmbH — Composite Orthodontic Brackets and Buttons (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 21, 2025device 510k
    ← prev
    page 37 of 100
    next →
    463d ago
    Asahi Intecc Co., Ltd. — CHIKAI Nexus 014 (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 21, 2025device 510k463d agoShenzhen TPH Technology Co., Ltd. — Wearable breast pump (model S12A) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Apr 21, 2025device 510k463d agoD.A.N.D. Metal Industries North, Ltd. — DAND Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 21, 2025device 510k463d agoGE Medical Systems SCS — VersaViewer (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 21, 2025device 510k463d agoDk Medical Technology Co., Ltd. — D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 21, 2025device 510k463d agoSpectrum Antimicrobials, Inc. — Spectricept Skin and Wound Cleanser (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 22, 2025device 510k462d agoMedtronic Sofamor Danek USA, Inc. — Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Apr 22, 2025device 510k462d agoOcusciences, Inc. — OcuMet Beacon (OCUB100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 22, 2025device 510k462d agoEvoden Indústria Comércio Importação E Exportação — Evoblock, Perléon (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 22, 2025device 510k462d agoJeil Medical Corporation — ARIX Femur Nail System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 22, 2025device 510k462d agoMedentika GmbH — Medentika CAD/CAM Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 22, 2025device 510k462d agoGoodman Co., Ltd. — Aperta NSE PTA Balloon Dilatation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 22, 2025device 510k462d agoAcuity Surgical Devices, LLC — Ventris Intervertebral Body Fusion Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 22, 2025device 510k462d agoBd Integrated Diagnostic Solutions/Becton, — BD CTGCTV2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 23, 2025device 510k461d agoHycor Biomedical — NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›Apr 23, 2025device 510k461d agoShenzhen Kingboom Technology Co., Ltd. — Electric Nasal Aspirator (BC026, BC025, BC023) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Apr 23, 2025device 510k461d agoMedacta International S.A. — Mpact 3D Metal Augments II (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Apr 23, 2025device 510k461d agoSofradim Production — Parietene™ Macroporous Mesh (PPM5050 ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 23, 2025device 510k461d agoNewclip Technics — Xpert Knee (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 23, 2025device 510k461d agoGmp Medicare Sdn. Bhd. — Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl (510k cleared)NutriBand Inc.

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

    full page →fda device 510k ↗
    ›Apr 23, 2025device 510k461d agoLEM Surgical AG — Dynamis Robotic Surgical System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 23, 2025device 510k461d agoEsonic Technology (Wuhan) Co., Ltd. — eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 23, 2025device 510k461d agoAnnalise-Ai — Annalise Enterprise (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 23, 2025device 510k461d agoSonavex, Inc. — EchoGuide (Version 1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 23, 2025device 510k461d agoLaon Medi, Inc. — Laon Ortho (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 23, 2025device 510k461d agoMedacta International S.A. — MySpine WebPlanner (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k460d agoSurGenTec, LLC — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k460d agoFreespira, Inc. — Freespira Breathing System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k460d agoShenzhen AOJ Medical Technology Co., Ltd. — Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k460d agoShenzhen Rogin Medical Co., Ltd. — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k460d agoIvylaser (Beijing) Technology Co.,Ltd — Diode laser system (Night Universe; Predator) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k460d agoZhuozhou Summer Star Technologies Co., Ltd. — CO2 Laser System (CO2 Laser SST-L23) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k460d agoGo-Pen Aps — GO-PEN® (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k460d agoMentor Worldwide, LLC — MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k460d 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 ↗
    ›Apr 24, 2025device 510k460d agoSound Health Systems, Inc. — Sonu (510k cleared)Tivic Health Systems, Inc.

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k460d agoCirca Scientific, Inc. — PeriCross™ Epicardial Access Kit (510k cleared)Clear Scientific Inc

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k460d agoLife Spark Medical, LLC — Smart Check O2 (MA0236) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k460d agoCanwell Medical Co., Ltd. — CanMINI Hand and Foot System (510k cleared)

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

    full page →fda device 510k ↗
    $ZBH87.97+0.93%
    $NTRB2.9000-11.59%
    $FRTRY
    $ISRG356.83+5.73%
    $TIVC
    $FRTRY