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22,353 catalysts · 4,728 grant · 4,406 device 510k · 3,288 8k filing · 3,188 approval · 2,000 device pma · 2,000 device recall

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type
  • grant4,728
  • device 510k4,406
  • 8k filing3,288
  • approval3,188
  • device pma2,000
  • device recall2,000
recall
1,078
  • device adverse event1,000
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Dec 16, 2024

    50
    ›Dec 19, 2024device 510k603d agoOrthofix Srl — OrthoNext Platform System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoInnocare Optoelectronics Corp. — Yushan X-Ray Flat Panel Detector (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoCollagen Matrix, Inc. — Bovine Dermis Collagen Dermal Matrix (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoCristaline Aligners GmbH — Cristaline Aligners Z FLX (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoDeepHealth, Inc. — Saige-Density (2.5.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoMedline Industries, LP — Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoBecton, Dickinson and Company — BD Vaginal Panel (510k cleared)BECTON DICKINSON & CO

    Product code: PQA. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoDeepHealth, Inc. — Saige-Dx (3.1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoQuickdent Devices Private , Ltd. — Quickdent Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoShanghai Sigma High-Tech Co., Ltd. — UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoSynchrony Medical , Ltd. — LibAirty Airway Clearance System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoStryker Neurovascular — Echo Intracranial Base Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoShenzhen Aozemei Technology Co., Ltd. — Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoShenzhen Nuon Medical Equipment Co., Ltd. — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole 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 ↗
    ›Dec 19, 2024device 510k603d agoImplant Protesis Dental 2004, S.L. — IPD Dental Implant Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoOnward Medical, Inc. — ARC-EX System (510k cleared)Picard Medical, Inc.

    Product code: SDO. Advisory committee: Physical Medicine. Type: Direct

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoMedline Industries, LP — Hudson RCI Comfort Flo® CubCannula™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoImbio, Inc. — IQ-UIP (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoDmc Importacao E Exportacao DE Equipamentos Ltda — Therapy EC, Therapy XT (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoSimpson Interventions, Inc. — Shadow Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoQuantumtx Pte. , Ltd. — Quantum Mitohormesis (QMT) (M2101) (510k cleared)

    Product code: IPF. Advisory committee: Physical Medicine. Type: Abbreviated

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoVivosonic, Inc. — Integrity V500 (Integrity, Integrity with VEMP) (510k cleared)VIVOS INC

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k603d agoTELA Bio, Inc. — OviTex PRS (Long-Term Resorbable) (510k cleared)TELA Bio, Inc.

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

    full page →fda device 510k ↗
    ›Dec 20, 2024approval602d agoSKYCLARYS (OMAVELOXOLONE) — FDA approvalReata Pharmaceuticals Inc

    Sponsor: BIOGEN US. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 20, 2024approval602d agoSKYCLARYS (OMAVELOXOLONE) — FDA approvalReata Pharmaceuticals Inc

    Sponsor: BIOGEN US. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 20, 2024approval602d agoALYFTREK (DEUTIVACAFTOR) — FDA approval(deutivacaftor + tezacaftor + vanzacaftor calcium)

    Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

    full page →(deutivacaftor + tezacaftor + vanzacaftor calcium) →fda approvals ↗
    ›Dec 20, 2024approval602d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

    Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

    full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
    ›Dec 20, 2024approval602d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

    Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

    full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
    ›Dec 20, 2024approval602d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

    Sponsor: VERTEX PHARMS INC. Form: GRANULES. Route: ORAL

    full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
    ›Dec 20, 2024approval602d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

    Sponsor: VERTEX PHARMS INC. Form: GRANULES. Route: ORAL

    full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
    ›Dec 20, 2024approval602d agoIMCIVREE (SETMELANOTIDE ACETATE) — FDA approvalsetmelanotide

    Sponsor: RHYTHM. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →setmelanotide →fda approvals ↗
    ›Dec 20, 2024approval602d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Dec 20, 2024approval602d agoBRAFTOVI (ENCORAFENIB) — FDA approvalencorafenib

    Sponsor: ARRAY BIOPHARMA INC. Form: CAPSULE. Route: ORAL

    full page →encorafenib →fda approvals ↗
    ›Dec 20, 2024approval602d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

    full page →PYZCHIVA →fda approvals ↗
    ›Dec 20, 2024approval602d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →PYZCHIVA →fda approvals ↗
    ›Dec 20, 2024approval602d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →PYZCHIVA →fda approvals ↗
    ›Dec 20, 2024approval602d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

    Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 20, 2024approval602d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

    Sponsor: PHARMACYCLICS LLC. Form: SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 20, 2024approval602d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

    Sponsor: PHARMACYCLICS LLC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 20, 2024device 510k602d agoAndon Health Co, Ltd. — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k602d agoOkami Medical, Inc. — SENDERO MAX Delivery Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k602d agoRizhao Huge Biomaterials Company, Ltd. — HF-Etchant Hydrofluoric Acid Etching Gel (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k602d agoShenzhen Root Innovation Technology Co., Ltd. — Momcozy Wearable Breast Pump (BP311) (510k cleared)Hang Feng Technology Innovation Co., Ltd.

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k602d agoZimmer Biomet — Zimmer® Persona® Personalized Knee System (510k cleared)ZIMMER BIOMET HOLDINGS, INC.

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k602d agoBeijing Adss Development Co., Ltd. — Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k602d agoVydence Medical — HandPICO Fractional Laser Handpiece Tip (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k602d agoLichtmega Technology Co., Ltd. — Scooter (PS30) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k602d agoSkingrab Co., Ltd. — Finiff System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k602d agoDiality, Inc. — Moda-flx Hemodialysis System™ Cartridge (102121-001 ) (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $TELA
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    $RDGL
    $FRTRY
    $VERX13.25+7.72%
    $VERX13.25+7.72%
    $LLY1209.00-0.92%
    $VERX13.25+7.72%
    $VERX13.25+7.72%
    $FOFO3.0000+2.39%
    $RYTM116.02-1.34%
    $ABBV250.82+0.83%
    $ABBV250.82+0.83%
    $AVBP30.00-4.64%
    $ABBV250.82+0.83%
    $ZBH87.97+0.93%