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4,582 catalysts · 4,728 grant · 4,582 device 510k · 3,606 8k filing · 3,233 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2024-11-12×clear all
type
  • grant4,728
  • device 510k4,582
  • 8k filing3,606
  • approval3,233
  • device pma2,000
  • device recall2,000
recall
1,107
  • device adverse event1,000
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Nov 11, 2024

    50
    ›Nov 12, 2024device 510k658d agoPhenox, Ltd. — pNOVUS 21 Microcatheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 12, 2024device 510k658d 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 510k658d 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 510k658d 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 510k658d 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 510k658d 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 510k658d 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 510k658d 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 510k658d 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 510k658d 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 510k658d 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 510k658d 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 510k657d agoCorvent Medical, Inc. — RESPOND(R) Ventilator (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 13, 2024device 510k657d 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 510k657d 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 510k657d 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 510k657d 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 510k657d 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 510k657d 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 510k657d 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 510k656d 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 510k656d 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 510k656d 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 510k656d agoHinlab Sas — Hinscope (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2024device 510k656d 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 510k656d agoWontech Co., Ltd. — Veincare (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2024device 510k656d 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 510k656d 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 510k656d 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 510k656d agoBrightheart — Fetal EchoScan (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d 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 510k655d 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 ↗
    ›Nov 15, 2024device 510k655d agoDent4you AG — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoCarlsmed, Inc. — aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoVuno, Inc. — VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoKoios Medical, Inc. — Koios DS (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoVascutek, Ltd. — Gelsoft™ Plus Vascular Prostheses (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoTianjin Huahong Technology Co., Ltd. — Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoMycardium AI Limited — 1CMR Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoCreagh Medical Ltd. Dba Surmodics, Inc. — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoUltromics Limited — EchoGo Amyloidosis (1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoPhilips Ultrasound, LLC — The 5000 Compact Series Ultrasound Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoVieworks Co., Ltd. — VIVIX-S 1751S (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoBlue Belt Technologies, Inc. — CORIOGRAPH Pre-Op Planning and Modeling Services (510k cleared)BETA Technologies, Inc.

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoShenzhen Vitavitro Biotech Co., Ltd. — VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) (510k cleared)Shenzhen MagicRNA Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoInfinitum Eta, Ltd. — NUVENTUS NV.C™ Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoB-One Ortho, Corp. — b-ONE® Total Hip System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoTHINK Surgical, Inc. — TMINI Miniature Robotic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoSurgical Instrument Service and Savings Inc.(Dba Medline Ren — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k655d agoSiemens Medical Solutions USA, Inc. — ACUSON Redwood Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $BETA16.10+2.09%
    $CARL
    $HKPD
    $STE233.78+0.35%
    $BSX46.84+0.36%
    $TNON0.2832-3.11%
    $CLPT
    $VYCO0.06600.00%
    $INMD