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23,528 catalysts · 5,000 device 510k · 4,728 grant · 3,696 approval · 3,313 8k filing · 2,000 device pma · 2,000 device recall

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  • device 510k5,000
  • grant4,728
  • approval3,696
  • 8k filing3,313
  • 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

    49
    ›Oct 23, 2024device 510k661d agoSpineart SA — Scarlet® AL-T (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k661d 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 510k661d 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 510k661d 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 510k661d agoBiomet 3i, LLC — Immediate Molar Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k661d 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 510k661d 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 510k661d 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, 2024approval660d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

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

    full page →fda approvals ↗
    ›Oct 24, 2024approval660d agoFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) — FDA approvalParatek Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Oct 24, 2024approval660d 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, 2024approval660d agoJUBBONTI (DENOSUMAB-BBDZ) — FDA approvalJUBBONTI

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

    full page →JUBBONTI →fda approvals ↗
    ›Oct 24, 2024approval660d agoHEPARIN SODIUM — FDA approvalHEPARIN SODIUM

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →HEPARIN SODIUM →fda approvals ↗
    ›Oct 24, 2024device 510k660d 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 510k660d 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 510k660d 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 510k660d 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 510k660d 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 510k660d 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 510k660d agoArgen Corporation — ArgenZ MTZ (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k660d agoKeystone Industries — KeyPrint KeyDenture Base (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k660d 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 510k660d 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 510k660d 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, 2024approval659d agoNOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

    full page →POSACONAZOLE →fda approvals ↗
    ›Oct 25, 2024approval659d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

    full page →POSACONAZOLE →fda approvals ↗
    ›Oct 25, 2024approval659d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

    Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Oct 25, 2024approval659d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

    full page →POSACONAZOLE →fda approvals ↗
    ›Oct 25, 2024approval659d agoORLYNVAH (PROBENECID) — FDA approvalLannett Co Inc

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

    full page →fda approvals ↗
    ›Oct 25, 2024device 510k659d agoSimBioSys, Inc. — TumorSight Viz (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d 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 ↗
    ›Oct 25, 2024device 510k659d agoShenzhen Yimi Life Technology Co., Ltd. — Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoNorlase Aps — LYNX Photocoagulator (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoAvanos Medical, Inc. — CORGRIP* SR NG/NI Tube Retention System (510k cleared)AVANOS MEDICAL, INC.

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoMetko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi — FMT Disposable and Autoclavable Temperature Probes (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoNeurophet., Inc. — Neurophet AQUA (V3.1) (510k cleared)NeurOp Inc

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoOrtho Development Corp. — BKS Revision System (510k cleared)DeFi Development Corp.

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoCryoconcepts LP — Freeze Point & Private Label Versions (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d ago3D Systems, Inc. — Cadence Ankle PSI System (510k cleared)3D SYSTEMS CORP

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoOcuject, LLC — LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle (510k cleared)

    Product code: QNS. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoDistalmotion SA — Dexter L6 System (510k cleared)

    Product code: SDD. Advisory committee: General, Plastic Surgery. Type: Direct

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoBruno Vision Care, LLC — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoUlike Co., Ltd. — Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d ago3D Systems, Inc. — Salto Talaris Ankle PSI System (510k cleared)3D SYSTEMS CORP

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoBiotronik, Inc. — Pantera Pro; Pantera LEO (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoQIAGEN GmbH — QIAstat-Dx Respiratory Panel Mini (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoVATECH Co., Ltd. — VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoCepheid® — Xpert® SA Nasal Complete (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k659d agoComfort Rubber Gloves Industries Sdn. Bhd. — Nitrile Powder Free Examination Gloves Biodegradable (Green) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Oct 28, 2024

    1
    ›Oct 28, 2024approval656d agoPOTASSIUM CHLORIDE — FDA approvalTWi Pharmaceuticals Inc

    Sponsor: TWI PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
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    $DFUKF
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    $FRTRY
    $FRTRY
    $DDD
    $XRAY11.58+1.49%
    $MRK134.93-0.46%
    $PFE26.61-0.73%