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23,674 catalysts · 5,000 device 510k · 4,728 grant · 3,966 approval · 3,189 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 82 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: 3 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: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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  • device 510k5,000
  • grant4,728
  • approval3,966
  • 8k filing3,189
  • device pma2,000
  • device recall2,000
  • recall1,126
  • 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 14, 2024

    39
    ›Oct 17, 2024device 510k665d agoHidroxa Medical AB — Hidroxa SE30 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoPerfuze, Ltd. — Zipline Access Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoGe Medical Systems, LLC — SIGNA MAGNUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoShenzhen Huaruibo Electric Appliances Co., Ltd. — IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoImbed Biosciences — Microlyte Ag/Lidocaine (510k cleared)Sustained Therapeutics Inc

    Product code: FRO. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoFimilla (Shanghai) Maternity & Baby Articles Co., Ltd. — Electric Breast Pump (F5055) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024approval664d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval664d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval664d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval664d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval664d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval664d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

    Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Oct 18, 2024approval664d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

    Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Oct 18, 2024approval664d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

    Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Oct 18, 2024approval664d agoORGOVYX (RELUGOLIX) — FDA approvalrelugolix

    Sponsor: SUMITOMO PHARMA AM. Form: TABLET. Route: ORAL

    full page →relugolix →fda approvals ↗
    ›Oct 18, 2024device 510k664d agoStimlabs, LLC — Corplex P/ Theracor P/ Allacor P (510k cleared)

    Product code: KGN. Advisory committee: Unknown. Type: Special

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoPhilips Medical Systems Nederland B.V. — dS Knee Coil 8ch 1.5T (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoDentscare Ltda — Vittra APS Unique Flow (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoOrthosoft Inc. (d/b/a) Zimmer CAS — ROSA® Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda — FREDDO (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoEclectic Co., Ltd. — PreXolid CAD/CAM abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoPhilips Medical Systems Technologies , Ltd. — Spectral CT 7500 RT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d ago3M Company — 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) (510k cleared)3M CO

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoMaterialise NV — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (510k cleared)MATERIALISE NV

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoSleepnet Corporation — Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoAcro Biomedical Co., Ltd. — ABCcolla® Collagen ADM Scaffold (510k cleared)ACRO BIOMEDICAL CO., LTD.

    Product code: KGN. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoSafepath Medical, Inc. — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoBone Solutions, Inc. — Mg OSTEOREVIVE™, Mg OSTEOCRETE™ (510k cleared)UL Solutions Inc.

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoEdelweiss Dentistry Products GmbH — edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoPhilips Medical Systems Nederland B.V. — dS Wrist coil 8ch 1.5T (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoBoston Scientific Corp — IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoWellmed Dental Medical Supply Co., Ltd. — Dental Barrier and Sleeves (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoWell-Life Healthcare Limited — Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoRestor3D — Kinos Total Ankle System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoMvision AI OY — Contour+ (MVision AI Segmentation) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoColoplast Corp. — Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoXiantao Daoqi Plastic Co., Ltd. — Surgical Face Mask (Tie on/ Ear loops) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoOystershell NV — Pixie Skin Tag (510k cleared)

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

    full page →fda device 510k ↗

    Week of Oct 21, 2024

    11
    ›Oct 21, 2024approval661d agoORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — FDA approvalberotralstat hydrochloride

    Sponsor: BIOCRYST. Form: CAPSULE. Route: ORAL

    full page →berotralstat hydrochloride →fda approvals ↗
    ›Oct 21, 2024device 510k
    ← prev
    page 14 of 474
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    661d ago
    Stryker Instruments — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2024device 510k661d agoiRhythm Technologies, Inc. — Zio AT® device (A100A1001) (510k cleared)TTM TECHNOLOGIES INC

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

    full page →fda device 510k ↗
    ›Oct 21, 2024device 510k661d agoApple, Inc. — Digital Prism Correction Feature (DPCF) (510k cleared)Apple Inc.

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

    full page →fda device 510k ↗
    ›Oct 21, 2024device 510k661d agoMomentis Surgical , Ltd. — Anovo Surgical System (Model 6Ne) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2024device 510k661d agoTalladium España, SL — Dynamic TiBase; TRI Screws (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2024device 510k661d agoArthrex, Inc. — Arthrex VAL and VAL KreuLock™ Compression Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2024device 510k661d agoSmith & Nephew, Inc. — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Oct 21, 2024device 510k661d agoSpeciality Fibres and Materials, Ltd. — Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch (510k cleared)

    Product code: FRO. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k660d agoBrosmed Medical Co., Ltd. — Tri-Wedge PTA Scoring Balloon Dilatation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k660d agoSiemens Medical Solutions USA, Inc. — ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) (510k cleared)

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

    full page →fda device 510k ↗
    $LLY1220.28+0.43%
    $ALVO4.0100+5.53%
    $LLY1220.28+0.43%
    $LLY1220.28+0.43%
    $LLY1220.28+0.43%
    $LLY1220.28+0.43%
    $ALVO4.0100+5.53%
    $MMM
    $ALVO4.0100+5.53%
    $ACBM
    $ULS
    $MTLS6.5600-1.06%
    $BCRX10.59+2.42%
    $BSX51.55+0.70%
    $TTMI
    $AAPL298.01+0.70%
    $SNN29.88-0.45%