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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 7, 2025

    7
    ›Apr 11, 2025device 510k473d agoShanghai AnQing Medical Instrument Co., Ltd. — Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoCascination AG — OTOPLAN (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoClick Therapeutics, Inc. — CT-132 (510k cleared)Click Holdings Ltd.

    Product code: SEE. Advisory committee: Neurology. Type: Direct

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoPearl, Inc. — Second Opinion Periapical Radiolucency Contours (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoRoche Molecular Systems, Inc. — cobas liat SARS-CoV-2 v2 nucleic acid test (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoMedline Industries, LP — Medline UNITE® REFLEX® Hybrid Nitinol Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoGalileo Cds, Inc. — GBrain MRI (510k cleared)

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

    full page →fda device 510k ↗

    Week of Apr 14, 2025

    43
    ›Apr 14, 2025device 510k470d agoElfi-Tech , Ltd. — Elfor-L (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 14, 2025device 510k
    ← prev
    page 36 of 100
    next →
    470d ago
    Mediclus Co., Ltd. — Any-Com Flow (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 14, 2025device 510k470d agoNeuralynx, Inc. — Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) (510k cleared)Neuraly Inc

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

    full page →fda device 510k ↗
    ›Apr 14, 2025device 510k470d agoMerge Healthcare Incorporated — Merge Universal Viewer (MUV) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 14, 2025device 510k470d agoAVAVA, Inc. — AVAVA™ Skin Treatment System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 14, 2025device 510k470d agoAdvanced Sterilization Products, Inc. — STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 15, 2025device 510k469d agoEMA Aesthetics , Ltd. — Préime DermaFacial Collagen+ (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 15, 2025device 510k469d agoCryoconcepts LP — Skin Clinic Nitro Clear Wart Remover (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 15, 2025device 510k469d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Apr 15, 2025device 510k469d agoArineta , Ltd. — SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 15, 2025device 510k469d agoSight Sciences, Inc. — TearCare MGX System (510k cleared)Sight Sciences, Inc.

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

    full page →fda device 510k ↗
    ›Apr 15, 2025device 510k469d agoBoston Scientific Corporation — Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set (510k cleared)BOSTON SCIENTIFIC CORP

    Product code: FAD. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Apr 15, 2025device 510k469d agoAnhui Deepblue Medical Technological Co., Ltd. — Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 15, 2025device 510k469d agoGeistlich Pharma AG — SwissMembrane X; SwissMembrane X Socket (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 15, 2025device 510k469d agoArk Surgical — LapBox Power Tissue Containment System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 15, 2025device 510k469d agoStryker Instruments — OptaBlate Radiofrequency (RF) Generator System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 15, 2025device 510k469d agoSteris — Electro Lube NXT (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›Apr 16, 2025device 510k468d agoLumenis Be, Ltd. — Stellar M22 (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 16, 2025device 510k468d agoClarius Mobile Health Corp. — Clarius Prostate AI (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 16, 2025device 510k468d agoLaralab GmbH — LARALAB (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 16, 2025device 510k468d agoNano-X Imaging , Ltd. — Nanox.ARC X (510k cleared)Nano-X Imaging Ltd.

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

    full page →fda device 510k ↗
    ›Apr 16, 2025device 510k468d agoNovasonix Technology S.L. — HEBE (NP0000763) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 16, 2025device 510k468d agoPneumowave, Ltd. — DCM (PW-DCM) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 16, 2025device 510k468d agoMysegmenter Technologies, Inc. — MySegmenter (v2.0.0) (510k cleared)Mylan Technologies Inc

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

    full page →fda device 510k ↗
    ›Apr 16, 2025device 510k468d agoMedyssey Co, Ltd. — Medyssey Navigation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoAlcresta Therapeutics, Inc. — RELiZORB (100300/100301) (510k cleared)Alcyone Therapeutics Inc

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

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoColoplast Corp. — Luja Set (510k cleared)

    Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoCarl Zeiss Meditec, Inc. — CLARUS (700) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoFluoptics Sas (A Getinge Group Company} — FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoShenzhen TPH Technology Co., Ltd. — Lacevo Wearable Breast Pump (Model S70) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoCorentec Co., Ltd. — EXULT Knee Replacement System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoBrain Ultimate, Inc. — Ultimate rTMS (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoEpi-Minder Pty, Ltd. — Minder System (510k cleared)

    Product code: SEM. Advisory committee: Neurology. Type: Direct

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoVitalconnect, Inc. — VitalRhythm (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoEnvision Endoscopy — SimpleStitch Suturing System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoBenq Materials Corporation — miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoRaySearch Laboratories AB (PUBL) — RayCare (2024A SP1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoYofo Medical Technology Co., Ltd. — Dental Cone Beam Computed Tomography System (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoImds Operations B.V. — FlowGuide (FG60F); GuidionShort (GS60F) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 17, 2025device 510k467d agoBrain Ultimate, Inc. — Ultimate rTMS for OCD (M-series) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 18, 2025device 510k466d agoKamiya Biomedical Company, LLC — K-ASSAY CRP (Ver.2) (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›Apr 18, 2025device 510k466d agoSTERIS Corporation — PADLOCK CLIP EFTR Kit (00713229) (510k cleared)STERIS plc

    Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Apr 18, 2025device 510k466d agoEcoray Co., Ltd. — ULTRA 1040 (510k cleared)

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

    full page →fda device 510k ↗
    $STE218.40+2.02%
    $STE218.40+2.02%
    $SGHT5.0300+2.44%
    $TMO447.81+1.31%
    $NNOX1.7300+1.17%
    $FRTRY
    $CLIK
    $BSX45.51+2.85%