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22,355 catalysts · 4,728 grant · 4,392 device 510k · 3,311 8k filing · 3,181 approval · 2,000 device pma · 2,000 device recall

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type
  • grant4,728
  • device 510k4,392
  • 8k filing3,311
  • approval3,181
  • device pma2,000
  • device recall2,000
  • recall1,078
  • 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 18, 2024device 510k605d agoArtsmedia Denmark Aps — ARTSMedia Semen Wash Medium (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoArtsmedia Denmark Aps — ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoNatec Medical , Ltd. — Amethyst HP PTA OTW 0.035 Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoSOADCO, S.L. — Klockner Kits (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoChongqing Moffy Innovation Technology Co., Ltd. — Respiratory Muscle Trainer (510k cleared)Hang Feng Technology Innovation Co., Ltd.

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoViasonix , Ltd. — Falcon/Xpress (Falcon/Xpress) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoCadwell Industries, Inc. — Bluebird Single-Use Respiratory Effort Belt (510k cleared)POWELL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoChangsha Anxiang Medical Technology Co., Ltd. — Tens & Ems Device (TU1080) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoDeltamed GmbH — 3Delta UNlimited (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoTeknimed Sas — GENTAFIX® (1, 3, 3MV) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoHunan Vathin Medical Instrument Co., Ltd. — Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoVentris Medical — Porous Biologic Scaffold (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoCaerus Corporation — Active System; Avenue8 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoQuest Medical, Inc. — Lyka® PORT Needle Free Access Device (4170Y) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoEtex Corporation — EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k605d agoFreudenberg Medical, LLC — FirstFit Surgical Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024approval604d agoGABAPENTIN — FDA approvalGABAPENTIN

    Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL

    full page →GABAPENTIN →fda approvals ↗
    ›Dec 19, 2024approval604d agoGABAPENTIN — FDA approvalGABAPENTIN

    Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL

    full page →GABAPENTIN →fda approvals ↗
    ›Dec 19, 2024approval604d agoGABAPENTIN — FDA approvalGABAPENTIN

    Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL

    full page →GABAPENTIN →fda approvals ↗
    ›Dec 19, 2024approval604d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

    Sponsor: ALKEM. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 19, 2024approval604d agoCEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

    Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

    full page →imiglucerase →fda approvals ↗
    ›Dec 19, 2024approval604d agoGABAPENTIN — FDA approvalGABAPENTIN

    Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL

    full page →GABAPENTIN →fda approvals ↗
    ›Dec 19, 2024approval604d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

    Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS

    full page →remdesivir →fda approvals ↗
    ›Dec 19, 2024device 510k604d agoCardinalhealth — Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) (510k cleared)CARDINAL HEALTH INC

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoWassenburg Medical, Inc. — System 83 Revolve Endoscope Washer/Disinfector (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoVygon USA — Nutrifit (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoYongkang Hengyi Vehicle Co., Ltd. — Electric Wheelchair (HC820N) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoStryker Neurovascular — Broadway 8 Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoJoytech Healthcare Co. , Ltd. — Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) (510k cleared)NVP Healthcare Co Ltd

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoOrthofix Srl — OrthoNext Platform System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d 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 510k604d 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 510k604d 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 510k604d 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 510k604d 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 510k604d 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 510k604d 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 510k604d 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 510k604d 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 510k604d 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 510k604d agoStryker Neurovascular — Echo Intracranial Base Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d 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 510k604d 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 510k604d 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 510k604d 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 510k604d 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 510k604d 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 510k604d agoImbio, Inc. — IQ-UIP (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d 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 510k604d agoSimpson Interventions, Inc. — Shadow Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $FRTRY
    $FOFO3.0000+2.39%
    $BDX181.97-0.88%
    $GILD138.14+1.67%
    $POWL
    $CAH231.24-1.25%
    $TMO447.81+1.31%
    $PMI0.1821-4.66%