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calendar

23,140 catalysts · 4,900 device 510k · 4,728 grant · 3,532 approval · 3,189 8k filing · 2,000 device pma · 2,000 device recall

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  • device 510k4,900
  • grant4,728
  • approval3,532
  • 8k filing3,189
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Nov 18, 2024

    50
    ›Nov 20, 2024device 510k631d agoExo, Inc. — Strain AI (SAI001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k631d agoShenzhen Ruiyi Business Technology Co., Ltd. — Leg Massager (Models:RP-ALM070H, RP-ALM071H) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k631d agoGostar Co., Ltd. — TD-7301 Spirometer (TD-7301) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k631d agoQ'Apel Medical, Inc. — Neurovascular Access System Family (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k631d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — HIGHERDOSE Red Light Hat (HG-120K) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024approval630d agoLICART (DICLOFENAC EPOLAMINE) — FDA approvalAmzell Limited

    Sponsor: IBSA INST BIO. Form: SYSTEM. Route: TOPICAL

    full page →fda approvals ↗
    ›Nov 21, 2024approval630d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

    Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Nov 21, 2024approval630d agoDICLOFENAC SODIUM — FDA approvalDICLOFENAC SODIUM

    Sponsor: AUROBINDO PHARMA USA. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →DICLOFENAC SODIUM →fda approvals ↗
    ›Nov 21, 2024approval630d agoPONSTEL (MEFENAMIC ACID) — FDA approvalAvion Pharmaceuticals LLC

    Sponsor: AVION PHARMS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2024approval630d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: ORAL

    full page →Midol →fda approvals ↗
    ›Nov 21, 2024approval630d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

    Sponsor: STEVENS J. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2024approval630d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

    Sponsor: BARR LABS INC. Form: TABLET. Route: ORAL

    full page →Midol →fda approvals ↗
    ›Nov 21, 2024approval630d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

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

    full page →hydrocodone bitartrate ER →fda approvals ↗
    ›Nov 21, 2024approval630d agoPERCODAN (ASPIRIN) — FDA approvalEndo Pharmaceuticals Inc

    Sponsor: ENDO OPERATIONS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2024approval630d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalANI PHARMACEUTICALS INC

    Sponsor: ANI PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2024approval630d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

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

    full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗
    ›Nov 21, 2024approval630d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

    Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2024approval630d agoSYNALGOS-DC (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

    Sponsor: SUN PHARM INDUSTRIES. Form: CAPSULE. Route: ORAL

    full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗
    ›Nov 21, 2024approval630d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

    Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2024approval630d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

    Sponsor: AMNEAL PHARMS NY. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2024approval630d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

    Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

    full page →hydrocodone bitartrate ER →fda approvals ↗
    ›Nov 21, 2024approval630d agoCARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: INGENUS PHARMS NJ. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2024device 510k630d agoFink Engineering Pty, Ltd. — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoVarian Medical Systems, Inc. — Gating Reflector Block (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoLifenet Health — PliaFX Flo (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoIlooda Co,., Ltd. — Secret MAX Multi-platform RF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoKonica Minolta, Inc. — SKR 3000 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoGM Dos Reis Industria e Comercio Ltda. — Versalock Mini and Micro Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoGeneral Vibronics, Inc. — MIRARI® Cold Plasma System ( GV-M2-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoSurGenTec, LLC — TiLink-P Joint Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoShenzhen Smallsignal Technology Co., Ltd. — Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoColoplast Corp. — Luja Coude (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoJazz Imaging — Jazz Classic (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoCepheid® — Xpert vanA (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoDepuy Ireland UC — ATTUNE™ Revision Hinge Knee (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoGM Dos Reis Industria e Comercio Ltda. — GMReis Ankle Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024approval629d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

    Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

    full page →teclistamab →fda approvals ↗
    ›Nov 22, 2024approval629d agoRAPIBLYK (LANDIOLOL HYDROCHLORIDE) — FDA approvalAOP Health

    Sponsor: AOP HLTH US. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Nov 22, 2024approval629d agoHYDROCODONE BITARTRATE AND ASPIRIN (ASPIRIN) — FDA approvalPurdue Pharma LP

    Sponsor: LGM PHARMA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 22, 2024approval629d agoLUNSUMIO (MOSUNETUZUMAB-AXGB) — FDA approvalmosunetuzumab

    Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION

    full page →mosunetuzumab →fda approvals ↗
    ›Nov 22, 2024approval629d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗
    ›Nov 22, 2024device 510k629d agoFlower Orthopedics Corporation Dba Conventus Flower Ortho — OsteoCoil™ Nitinol Compression System (Multiple Component PNs) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoPAJUNK GmbH Medizintechnologie — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoXf Agencija Limited — Nooro Body & Foot Stimulator (SM9141, SM9142) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoAdvamedix, GmbH — Suction Irrigation Tubing Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoNeuvotion, Inc. — Neuvotion NeuStim NN-01 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoNova Biomedical Corporation — Nova Allegro HbA1c Assay, Nova Allegro Analyzer (510k cleared)

    Product code: LCP. Advisory committee: Hematology. Type: Dual Track

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoZimmer, Inc. — Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoSichuan Ast Medical Equipment Co., Ltd. — Manual Wheelchair (MASY23) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoAidite (Qinhuangdao) Technology Co., Ltd. — Additively Manufactured Denture Resin (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $MMSI91.20+0.10%
    $ABBV248.76-0.53%
    $ANIP75.11+0.78%
    $CPIX7.9100-0.63%
    $BLNC