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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,415
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Jan 27, 2025

    45
    ›Jan 27, 2025device 510k545d agoMedical Microinstruments, Inc. — Symani Surgical System (820-03830) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 27, 2025device 510k545d agoRaysolution Healthcare Co., Ltd. — Imaging system of positron emission and X-ray computed tomography (DigitMI 930) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 27, 2025device 510k545d agoBunkerHill Health — Bunkerhill AVC (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k544d agoShenzhen Rainbow Technology Co., Ltd. — LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k544d agoBrainlab AG — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k544d agoHuxley Medical — SANSA HSAT (510k cleared)

    Product code: MNR. Advisory committee: Anesthesiology. Type: Special

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k544d agoConmed Corporation — Argo Knotless GENESYS Anchor (510k cleared)CONMED Corp

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

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k544d ago3M Company — 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (510k cleared)3M CO

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

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k544d agoInstrumentation Laboratory (IL) Co. — HemosIL CL HIT-IgG(PF4-H) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k544d agoLg Electronics.Inc — Medical Monitor (27HS714S) (510k cleared)ARROW ELECTRONICS, INC.

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k543d agoGyder Surgical Pty, Ltd. — GYDER® Hip System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k543d agoGM Dos Reis Industria e Comercio Ltda. — Versalock Upper Limb Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k543d agoSurcam Medical Devices and Developments, Ltd. — Surcam Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k543d agoHunan Vathin Medical Instrument Co., Ltd. — Digital Video Processor (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k543d agoGI Windows, Inc. — Self-Forming Magnet (FLEX SFM) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k543d agoXenco Medical, LLC — Xenco Medical CancelleX Cervical Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k543d agoAccess Bio, Inc. — CareSuperb™ COVID-19 Antigen Home Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k543d agoHygea Medical Technology Co., Ltd. — Co-Ablation System with Sterile Co-Ablation Probe (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k542d agoMobius Mobility — iBOT® PMD (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k542d agoShenzhen Zhongkemingwang Telecommunications Software Corp. — Wrist Blood Pressure Monitor (OHMS11, OHMS12) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k542d agoMedacta International S.A. — MyShoulder Planner (5.3SSWPL) (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k542d agoResponsive Arthroscopy, Inc. — Osprey Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k542d agoBTL Industries, Inc. — BTL-754 (510k cleared)NL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k542d agoLaboratorios Biogalenic S.A. DE C.V. — Laboratorios Biogalenic Sterile Water for Inhalation, USP (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k542d agoAbanza Tecnomed S.L — WasherCap™ Mini Fixation System (Model 45) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k542d agoTaiwan Aulisa Medical Devices Technologies, Inc. — Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k542d agoSeplou (Zhuhai) Co., Ltd. — Ureteral Access Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k542d agoLiofilchem s.r.l. — MTS Ceftobiprole 0.002-32 µg/mL (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k542d agoAbbott Molecular — simpli-COLLECT STI Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k542d agoBard Peripheral Vascular, Inc. — Rotarex Atherectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k542d agoGuangdong Transtek Medical Electronics Co., Ltd. — TeleRPM Gen2 Blood Glucose Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k541d agoAvanos Medical, Inc. — Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La (510k cleared)AVANOS MEDICAL, INC.

    Product code: IRP. Advisory committee: Physical Medicine. Type: Special

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k541d agoZheJiang Decans Medical Devices Co., Ltd. — Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k541d agoMarzzan Lucas Jorge — AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k541d agoLuxottica Group S.P.A. — Nuance Audio Hearing Aid Software (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k541d agoSuzhou Master Machinery Manufacturing Co.,Ltd — Mobility Scooter (MS160A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k541d agoNanjing Synthgene Medical Technology Co., Ltd. — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k541d agoMotilitycount Aps — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k541d agoDornier Medtech America — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k541d agoArthrex, Inc. — Arthrex DynaNite Nitinol Staples (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k541d agoBasic Medical Technology, Inc. — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k541d agoTae Young Soft Co., Ltd. — ZeTTA PACS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k541d agoGentuity, LLC — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k541d agoInnovate Orthopaedics, Ltd. — Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k541d agoC.R. Bard, Inc. — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, (510k cleared)

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

    full page →fda device 510k ↗

    Week of Feb 3, 2025

    5
    ›Feb 3, 2025device 510k538d agoHuntleigh Healthcare , Ltd. — Sonicaid Team3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k
    ← prev
    page 23 of 100
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    538d ago
    Momentis Surgical , Ltd. — Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k538d agoShenzhen Ulike Smart Electronics Co., Ltd. — JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k538d agoGuangzhou Hehong Biotech Co., Ltd. — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k538d agoCytochip, Inc. — Cito CBC System (510k cleared)

    Product code: GKZ. Advisory committee: Hematology. Type: Dual Track

    full page →fda device 510k ↗
    $MMM
    $FRTRY
    $AVNS
    $NL6.0500-1.14%
    $MDCE0.00020.00%
    $ARW226.78+1.76%
    $CNMD32.58+1.46%