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4,138 catalysts · 4,728 grant · 4,138 device 510k · 3,605 8k filing · 3,132 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2024-12-25×clear all
type
  • grant4,728
  • device 510k4,138
  • 8k filing3,605
  • approval3,132
  • device pma2,000
  • device recall2,000
recall
1,003
  • device adverse event1,000
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Dec 23, 2024

    17
    ›Dec 26, 2024device 510k613d agoInstitut Straumann AG — Straumann CARES Visual and Nova Dental CAD (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 26, 2024device 510k613d agoTreace Medical Concepts — TMC Compression Implant System (510k cleared)TREACE MEDICAL CONCEPTS, INC.

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

    full page →fda device 510k ↗
    ›Dec 26, 2024device 510k613d agoJiangxi Medex Technology Co., Ltd. — Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) (510k cleared)Jiangsu Maoxing Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Dec 26, 2024device 510k613d agoGolden Star Srl — FISIOWARM 7.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 26, 2024device 510k613d agoEpic Medical Pte. , Ltd. — ProSeal™ Vented Universal Vial Adaptor (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 26, 2024device 510k613d agoShanghai Wonderful Opto-Electrics Tech.Co.,Ltd — Diode Laser System model Dawn-S (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 26, 2024device 510k613d agoBomtech Electronics Co., Ltd. — RM STAR EX with RMS Needle (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 26, 2024device 510k613d agoPacira Biosciences, Inc. — iovera° System (510k cleared)Pacira BioSciences, Inc.

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

    full page →fda device 510k ↗
    ›Dec 27, 2024device 510k612d agoBeijing Okvd Biological Technology , Ltd. — Elastic Impression Material (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 27, 2024device 510k612d agoAnhui Jbh Medical Apparatus Co., Ltd. — Power Wheelchair (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 27, 2024device 510k612d agoTechsomed Medical Technologies , Ltd. — BioTraceIO Precision (2.0) (510k cleared)KESTRA MEDICAL TECHNOLOGIES, LTD.

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

    full page →fda device 510k ↗
    ›Dec 27, 2024device 510k612d agoCowellmedi Co., Ltd. — INNO SLA Mini Plus® Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 27, 2024device 510k612d agoGe Hualun Medical Systems Co. , Ltd. — OEC One ASD (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 27, 2024device 510k612d agoMegagen Implant Co., Ltd. — BLUEDIAMOND IMPLANT (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 27, 2024device 510k612d ago7D Surgical ULC — FLASH EVD System (10-0002) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 27, 2024device 510k612d agoSurGenTec, LLC — TiLink-P SI Joint Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 28, 2024device 510k611d agoShenzhen Beacon Display Technology Co., Ltd. — 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T (510k cleared)

    Product code: PZZ. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗

    Week of Dec 30, 2024

    33
    ›Dec 30, 2024device 510k609d agoMicroaire Surgical Instruments, LLC — PAL Aspiration System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 30, 2024device 510k
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    page 1 of 83
    next →
    609d ago
    Balt USA, LLC — Next Generation Access Platform (510k cleared)Bayer USA LLC

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

    full page →fda device 510k ↗
    ›Dec 30, 2024device 510k609d agoBios S.R.L. — Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 30, 2024device 510k609d agoRespironics, Inc. — AF531 Oro-Nasal SE Face Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 31, 2024device 510k608d agoAvita Corporation — Nasal Aspirator (NS 13) (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Dec 31, 2024device 510k608d agoNanjing E-Take Medical Apparatus Co., Ltd. — Electric Wheelchair (MODEL H) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 31, 2024device 510k608d agoClariance — Idys® LIF (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 31, 2024device 510k608d agoAnhui Jbh Medical Apparatus Co., Ltd. — Power Wheelchair (D10, D12, D15, D17, D20, D37) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 31, 2024device 510k608d agoGenadyne Biotechnologies, Inc. — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) (510k cleared)POP Biotechnologies Inc

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

    full page →fda device 510k ↗
    ›Dec 31, 2024device 510k608d agoABBOTT MEDICAL — MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 31, 2024device 510k608d agoChongqing Moffy Innovation Technology Co., Ltd. — Peak Flow Meter (510k cleared)Hang Feng Technology Innovation Co., Ltd.

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

    full page →fda device 510k ↗
    ›Jan 2, 2025device 510k606d agoJiangxi Zhuoruihua Medical Instrument Co., Ltd. — Haemostasis Clips (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2025device 510k606d agoEzra Ai, Inc. — Ezra Flash (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2025device 510k606d agoGreenMark Biomedical, Inc. — CrystLCare™ PRO Biorestorative, Fluoride-Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2025device 510k606d agoBionit Labs Srl — Wave Electrode (AE02-60); Wave Electrode (AE02-50) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2025device 510k606d agoMicro Therapeutics, Inc. d/b/a ev3 Neurovascular — Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2025device 510k606d agoOrtho Ai, LLC — Ortho AI (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2025device 510k606d agoHunan Accurate Bio-Medical Technology Co., Ltd. — Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2025device 510k606d agoDongguan Laiguang Electronic Technology Co., Ltd. — Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2025device 510k606d agoAnhui Jbh Medical Apparatus Co., Ltd. — Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k605d agoPentax of America, Inc. — PENTAX Medical Video Colonoscope (EC38-i20cWL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k605d agoInbella Medical, Inc. — Inbella RF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k605d agoEunsung Global Corp — DUET-V (Model: ESK-3261DV) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k605d agoProimtech Saglik Urunleri Anonim Sirketi — GBR System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k605d agoDk Medical System — INNOVISION-EXII (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k605d agoSiemens Medical Solutions USA, Inc. — syngo.CT Dual Energy (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k605d agoAbbott Point of Care, Inc. — i-STAT hs-TnI cartridge with the i-STAT 1 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k605d agoInventis S.R.L. — Synapsys VHIT (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k605d agoMallinckrodt Manufacturing, LLC — EVOLVE Nitric Oxide Delivery System (510k cleared)Mallinckrodt LLC

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k605d agoNobel Biocare AB — NobelProcera Zirconia Implant Bridge (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k605d agoZinkh NV — Elemental Granulate (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k605d agoOrmco Corporation — Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k605d agoGe Medical Systems Israel, Functional Imaging — Clarify DL (510k cleared)

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

    full page →fda device 510k ↗
    $KMTS20.35+8.13%
    $TMCI4.1900+4.49%
    $PCRX25.76-0.27%
    $FOFO3.0000+2.39%