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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,779 phase readout · 4,728 grant · 2,387 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,779
  • grant4,728
  • 8k filing2,387
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Nov 4, 2024

    17
    ›Nov 8, 2024device 510k623d agoiSMART Developments, Ltd. — décoLITE LED Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoGeistlich Pharma AG — Device 300397 Putty (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoHermes Medical Solutions AB — Hybrid Viewer (00859873006189) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoFourth Frontier Technologies Pvt, Ltd. — Frontier X Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoNvision Biomedical Technologies — Trigon PEEK HA Wedges (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoHironic Co., Ltd. — Plasonic (Plasonic) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoJeil Medical Corporation — Xpine Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoShenzhen Nuon Medical Equipment Co., Ltd. — Hair Growth Comb (SZ-23,SZ-23A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoSonoma Pharmaceuticals, Inc. — Microdacyn Hydrogel (510k cleared)Sonoma Pharmaceuticals, Inc.

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoPulnovo Medical (Wuxi) Co., Ltd. — Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoHangzhou Clongene Biotech Co., Ltd. — CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoGuangzhou Aimira Innovation Technology Co, Ltd. — Superflow Prime Treatment System (ASP-1M) (510k cleared)Hang Feng Technology Innovation Co., Ltd.

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoWaldemar Link GmbH & Co. KG — MobileLink Acetabular Cup System - Line Extension (Multiple) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoRizhao Huge Biomaterials Company, Ltd. — TopCEM Ceramic Primer Ceramic Coupling Agent (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoSTERIS Corporation — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›Nov 9, 2024device 510k622d agoS4 Medical Corp. — esolution® Esophageal Retractor (510k cleared)Medicale Corp.

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

    full page →fda device 510k ↗

    Week of Nov 11, 2024

    33
    ›Nov 11, 2024device 510k620d agoStraumann USA, LLC — Straumann® Anatomic Healing Abutments XC (AHA) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2024device 510k
    ← prev
    page 9 of 100
    next →
    619d ago
    Phenox, Ltd. — pNOVUS 21 Microcatheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2024device 510k619d agoFoshan Soco Precision Instrument Co., Ltd. — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2024device 510k619d agoSteris — VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator (510k cleared)STERIS plc

    Product code: SDC. Advisory committee: General Hospital. Type: Direct

    full page →fda device 510k ↗
    ›Nov 12, 2024device 510k619d agoPrognosys Medical Systems Private Limited — PRORAD X-Ray Flat Panel Detector with DROC (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2024device 510k619d agoChange Healthcare Canada Company — Change Healthcare Stratus Imaging PACS (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2024device 510k619d agoVyaire Medical, Inc. — AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask (510k cleared)VYCOR MEDICAL INC

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

    full page →fda device 510k ↗
    ›Nov 12, 2024device 510k619d agoMedtronic Minimed — InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2024device 510k619d agoSoul Mobility — Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2024device 510k619d agoLifesignals, Inc. — UbiqVue™ 2A Multi-parameter System (UX2550) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2024device 510k619d agoZhejiang Kairui Medical Device Co., Ltd. — Electric wheelchair (KR-8807) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2024device 510k619d agoColoplast Corp. — Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2024device 510k619d agoSupermax Healthcare Canada – Supermax Medical — Aurelia Surgical Mask ASTM Level-3 (2130) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 13, 2024device 510k618d agoCorvent Medical, Inc. — RESPOND(R) Ventilator (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 13, 2024device 510k618d agoHunan Vsmile Biotechnology Co., Ltd. — Dental Glass Ceramics Blocks (HT, LT, MT) (510k cleared)Cellyan Biotechnology Co., Ltd

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

    full page →fda device 510k ↗
    ›Nov 13, 2024device 510k618d agoGuangdong Jinme Medical Technology Co., Ltd. — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) (510k cleared)Chongqing Jinsaixing Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 13, 2024device 510k618d agoClearPoint Neuro, Inc. — SmartFlow Neuro Cannula (510k cleared)ClearPoint Neuro, Inc.

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

    full page →fda device 510k ↗
    ›Nov 13, 2024device 510k618d agoHuizhou Foryou Medical Devices Co., Ltd. — LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 13, 2024device 510k618d agoCequr SA — CeQur Simplicity™ On-Demand Insulin Delivery System (510k cleared)Shanghai Jiao Tong University

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

    full page →fda device 510k ↗
    ›Nov 13, 2024device 510k618d agoNonin Medical, Inc. — Nonin OTC Pulse Oximeter Model 3250 (510k cleared)Tenon Medical, Inc.

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

    full page →fda device 510k ↗
    ›Nov 13, 2024device 510k618d agoCmf Medicon Surgical, Inc. — MediRod Pedicle Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2024device 510k617d agoShenzhen Xinrun Electric Appliances Co, Ltd. — Xrecovery (XR-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2024device 510k617d agoSkeletal Dynamics, Inc. — Proximal Humerus Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2024device 510k617d agoNanjing Bestview Laser S&T Co., Ltd. — Intense Pulsed Light Treatment System (LK-PT) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2024device 510k617d agoHinlab Sas — Hinscope (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2024device 510k617d agoInMode , Ltd. — DEFINE System (AG612444A) (510k cleared)InMode Ltd.

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

    full page →fda device 510k ↗
    ›Nov 14, 2024device 510k617d agoWontech Co., Ltd. — Veincare (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2024device 510k617d agoMicroware Precision Co., Ltd. — Tandry Q-Locking Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2024device 510k617d agoArthrex, Inc. — Arthrex Elbow Fracture Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2024device 510k617d agoBesmed Health Business Corp — Besmed Bacterial Filter and HMEF (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2024device 510k617d agoBrightheart — Fetal EchoScan (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoBoston Scientific Corporation — AdVance™ XP Male Sling System (720163-03) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoHologic, Inc. — Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (510k cleared)

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

    full page →fda device 510k ↗
    $STE210.64+0.03%
    $FOFO3.0000+2.39%
    $SNOA
    $MCLE
    $CLPT
    $VYCO0.06600.00%
    $HKPD
    $STE210.64+0.03%
    $TNON0.2832-3.11%
    $INMD
    $BSX43.58+1.42%