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23,587 catalysts · 5,000 device 510k · 4,728 grant · 3,915 approval · 3,153 8k filing · 2,000 device pma · 2,000 device recall

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  • device 510k5,000
  • grant4,728
  • approval3,915
  • 8k filing3,153
  • 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 Oct 21, 2024

    50
    ›Oct 22, 2024device 510k660d agoAvita Corporation — Arm Type Blood Pressure Monitor (BPM82) (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k660d ago3-D Matrix Europe SAS — PuraStat (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k660d agoNordicneurolab AS — nordicMEDiVA (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k660d agoStryker Sustainability Solutions — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k660d agoShanghai SeeGen Photoelectric Technology Co., Ltd. — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k660d agoKarl Storz Endoscopy America, Inc. — KARL STORZ Holders (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k660d agoTianjin Mastervision Technology Co., Ltd. — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses (510k cleared)

    Product code: HQD. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 23, 2024approval659d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

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

    full page →eculizumab biosimilar →fda approvals ↗
    ›Oct 23, 2024approval659d agoVIGABATRIN — FDA approvalVIGABATRIN

    Sponsor: ACCORD HLTHCARE. Form: FOR SOLUTION. Route: ORAL

    full page →VIGABATRIN →fda approvals ↗
    ›Oct 23, 2024approval659d 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 ↗
    ›Oct 23, 2024device 510k659d agoL&K BIOMED Co., Ltd. — BluEX Lumbar Expandable Cage System (510k cleared)NeuCen BioMed Co Ltd

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoMim Software, Inc. — MIM – Symphony HDR Fusion (510k cleared)ASURE SOFTWARE INC

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoEpic Medical Pte. , Ltd. — ProSeal™ Closed System Bag Access (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoVarian Medical Systems — Vitesse (5.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoGuangdong Optomedic Technologies, Inc. — FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoMedtronic Sofamor Danek USA, Inc. — CD Horizon™ Spinal System (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoAdaptiiv Medical Technologies, Inc. — TrueFit Bolus; TrueFlex Bolus (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoDRTECH Corporation — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoAffinity Biosensors, LLC — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (510k cleared)

    Product code: SAN. Advisory committee: Microbiology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoSpineart SA — Scarlet® AL-T (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoThe Orthopaedic Implant Company — OIC Small / Mini Fragment Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoScivita Medical Technology Co., Ltd. — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoParagonix Technologies — KIDNEYvault Portable Renal Perfusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoBiomet 3i, LLC — Immediate Molar Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoWeifang Mingliang Electronics Co., Ltd. — Fractional CO2 Laser Therapy System (EXFU CO2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoImmunodiagnostic Systems Limited — IDS-iSYS Free Testosterone (510k cleared)Transdermal Delivery Solutions Corp

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k659d agoTsk Laboratory International Japan KK — STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024approval658d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

    Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗
    ›Oct 24, 2024approval658d agoFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) — FDA approvalParatek Pharmaceuticals Inc

    Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗
    ›Oct 24, 2024approval658d agoHEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM) — FDA approvalHEPARIN SODIUM

    Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

    full page →HEPARIN SODIUM →fda approvals ↗
    ›Oct 24, 2024approval658d agoJUBBONTI (DENOSUMAB-BBDZ) — FDA approvalJUBBONTI

    Sponsor: SANDOZ INC. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →JUBBONTI →fda approvals ↗
    ›Oct 24, 2024approval658d agoHEPARIN SODIUM — FDA approvalHEPARIN SODIUM

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →HEPARIN SODIUM →fda approvals ↗
    ›Oct 24, 2024device 510k658d agoTelefield Medical Imaging (Shenzhen) Limited — Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k658d agoMedtronic Neurosurgery — Duet External Drainage and Monitoring System (EDMS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k658d agoGt Metabolic Solutions, Inc. — MagDI System (MAG-01, DS-01) (510k cleared)Seed Health Inc

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k658d agoMedency S.R.L. — Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k658d agoDentsply Sirona — CEREC Cercon 4D CAD/CAM Blocks (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k658d agoImplantcast GmbH — MUTARS® femoral stem cemented 160 mm and 200 mm (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k658d agoArgen Corporation — ArgenZ MTZ (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k658d agoKeystone Industries — KeyPrint KeyDenture Base (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k658d agoShenzhen Urion Technology Co., Ltd. — Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k658d agoFoshan Shunkangda Medical Tech Co., Ltd. — Manual Wheelchair (SYIV100-CA9221) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k658d agoPhilips Medical Systems Nederland B.V. — ROCC Console (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024approval657d agoNOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approvalPOSACONAZOLE

    Sponsor: MSD MERCK CO. Form: FOR SUSPENSION, DELAYED RELEASE. Route: ORAL

    full page →POSACONAZOLE →fda approvals ↗
    ›Oct 25, 2024approval657d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

    Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

    full page →POSACONAZOLE →fda approvals ↗
    ›Oct 25, 2024approval657d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

    Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Oct 25, 2024approval657d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

    Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →POSACONAZOLE →fda approvals ↗
    ›Oct 25, 2024approval657d agoORLYNVAH (PROBENECID) — FDA approvalLannett Co Inc

    Sponsor: ITERUM THERAP. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 25, 2024device 510k657d agoSimBioSys, Inc. — TumorSight Viz (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k657d agoShenzhen Beacon Display Technology Co., Ltd. — LCD Monitors C310S, G310S, C316S, G316S, C616W (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $XRAY11.37-2.11%
    $MDCE0.00020.00%
    $PFE26.62-1.59%
    $AMGN414.30-0.70%
    $ASUR8.2700+1.35%
    $MRK130.42-0.38%
    $FRTRY