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5,000 catalysts · 18,987 approval · 5,811 phase readout · 5,000 device 510k · 4,728 grant · 2,984 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 0 catalysts2026-08-05: 0 catalysts2026-08-06: 0 catalysts2026-08-07: 0 catalysts2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 14 catalysts2026-08-11: 16 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 11 catalysts2026-10-29: 20 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,811
  • device 510k5,000
  • grant4,728
  • 8k filing2,984
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings572
  • therapy area

    no tagged catalysts yet

    Week of Mar 23, 2026

    5
    ›Mar 27, 2026device 510k135d agoAventix Medical, Inc. — AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) (510k cleared)AVITA Medical, Inc.

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoZhuhai Fitlens Medical Technology Co., Ltd. — GPA (hexafocon A) Rigid Gas Permeable Contact Lenses (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoLincotek Medical — SportLinc Syndesmosis Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2026device 510k134d agoSanhe Meditech Co., Ltd. — CO2 Laser System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2026device 510k134d agoAnumana, Inc. — ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Mar 30, 2026

    45
    ›Mar 30, 2026device 510k132d agoSpectrum Spine — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 30, 2026device 510k
    ← prev
    page 98 of 100
    next →
    132d ago
    Baebies, Inc. — FINDER Flu A&B/SARS-CoV-2 Test (510k cleared)

    Product code: QOF. Advisory committee: Microbiology. Type: Dual Track

    full page →fda device 510k ↗
    ›Mar 30, 2026device 510k132d agoBloomden Bioceramics (HuNan) Co., Ltd. — Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 30, 2026device 510k132d agoArthroCare Corporation — FLOW FLEXTEND Wand (72290039) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 30, 2026device 510k132d agoPhilips Medizin Systeme Böblingen GmbH — IntelliVue Measurement Rack 6000 (867317) (510k cleared)

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 30, 2026device 510k132d agoImplantcast GmbH — implantcast Packaging System Update (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 30, 2026device 510k132d agoCenters for Disease Control and Prevention — Francisella tularensis Real-time PCR Assay (510k cleared)Hubei Provincial Center for Disease Control and Prevention

    Product code: SGA. Advisory committee: Immunology. Type: Special

    full page →fda device 510k ↗
    ›Mar 30, 2026device 510k132d agoViTAA Medical Solutions, Inc. — AiORTA - Plan v2.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 30, 2026device 510k132d agoMayer Laboratories — Sagami Original 002 Polyurethane Male Condom (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 30, 2026device 510k132d agoAvatar Medical — Avatar Medical Vision (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2026device 510k131d agoZhenjiang Assure Medical Equipment Co., Ltd. — K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR)) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2026device 510k131d agoMediott, Inc. — RW-1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2026device 510k131d agoSanhe Meditech Co., Ltd. — Nd: YAG Laser Therapy Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2026device 510k131d agoTianjin Huahong Technology Co., Ltd. — Safety lancet (XXXVII) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2026device 510k131d agoCarbon Medical Technologies, Inc. — InjecSURE Injection System (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Mar 31, 2026device 510k131d agoVATECH Co., Ltd. — Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2026device 510k130d agoShenzhen HanHan Technology Co., Ltd. — Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) (510k cleared)Shenzhen Hanhui Pharmaceutical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 1, 2026device 510k130d agoStereotaxis, Inc. — Synchrony (510k cleared)Stereotaxis, Inc.

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

    full page →fda device 510k ↗
    ›Apr 1, 2026device 510k130d agoRetmap, Inc. — RM Electrode (RMH 25-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2026device 510k130d agoApple, Inc. — Medical Imaging Calibration Feature (MICF) (510k cleared)Apple Inc.

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

    full page →fda device 510k ↗
    ›Apr 1, 2026device 510k130d agoHudi Pharma Srl — Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2026device 510k130d agoShenzhen AOJ Medical Technology Co., Ltd. — Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 1, 2026device 510k130d agoNvision Biomedical Technologies, Inc. — enHAnce PEEK Bunion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2026device 510k130d agoPrana Surgical — Prana System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2026device 510k130d agoConvatec Limited — GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2026device 510k130d agoShenzhen RF Tech Co., Ltd. — GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2026device 510k130d agoSmart Soft Healthcare AD — CoLumbo C-Spine (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2026device 510k130d agoPoly Medicure Limited — Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2026device 510k130d agoOrthomod, LLC — MOD-C (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoMedical Brands Laboratories B.V. — Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoIcu Medical, Inc. — LifeShield Infusion Safety Software Suite (510k cleared)ICU MEDICAL INC/DE

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoShalby Advanced Technologies, Inc. Dba Consensus Orthopedics — Tahoe Unicondylar Knee System with TiNbN Overcoat (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoBeijing L&Z Medical Technology Development Co., Ltd. — Disposable Infusion Bag for Parenteral Nutrition (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoVerge Medical, Inc. — FLASH Flex™ Aorto-Ostial Angioplasty System (510k cleared)VYCOR MEDICAL INC

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoChengdu Cryo-Push Medical Technology Co.,Ltd — Cryopush Cold Compression Device (A02-P-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoEl.En S.P.A. — SPECCHIO (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoMiracell Co., Ltd. — SMART M-CELL PRP Concentration System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoBecton, Dickinson and Company — Onclarity™ Self-Collection Kit (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoMiracell Co., Ltd. — SMART M-CELL Bone Marrow Concentration System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoXuzhou Yongkang Electronic Science Technology Co., Ltd. — Wireless Probe Type Ultrasound Scanner (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoJeil Medical Corporation — Leforte MMF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoBecton Dickinson Infusion Therapy Systems, Inc. — BD Insyte™ IV Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoRoche Diagnostics — Tina-quant Cardiac high sensitivity CRP III (510k cleared)Dawn Sea Therapeutics

    Product code: NQD. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k129d agoGenoray Co., Ltd. — BELLIGER ACE (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k128d agoRadformation, Inc. — ClearCheck (RADCC V2.7) (510k cleared)

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

    full page →fda device 510k ↗
    $RCEL7.7700+63.58%
    $BDX176.86-0.12%
    $STXS1.8800+5.62%
    $AAPL298.01+0.70%
    $MDCE0.00020.00%
    $ICUI184.56+10.93%
    $VYCO0.06600.00%