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23,144 catalysts · 4,956 device 510k · 4,728 grant · 3,543 approval · 3,126 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 97 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: 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 510k4,956
  • grant4,728
  • approval3,543
  • 8k filing3,126
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Oct 14, 2024

    22
    ›Oct 18, 2024device 510k663d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k663d agoDentscare Ltda — Vittra APS Unique Flow (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d agoRestor3D — Kinos Total Ankle System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k663d 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 510k663d 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 510k663d 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 510k663d 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

    28
    ›Oct 21, 2024approval660d agoORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — FDA approvalberotralstat hydrochloride

    Sponsor: BIOCRYST. Form: CAPSULE. Route: ORAL

    full page →berotralstat hydrochloride →fda approvals ↗
    ›Oct 21, 2024device 510k
    ← prev
    page 5 of 463
    next →
    660d 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 510k660d 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 510k660d 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 510k660d 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 510k660d 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 510k660d 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 510k660d 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 510k660d 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 510k659d 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 510k659d 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 ↗
    ›Oct 22, 2024device 510k659d agoSol-Millennium Medical, Inc. — Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k659d 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 510k659d 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 510k659d agoNordicneurolab AS — nordicMEDiVA (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2024device 510k659d 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 510k659d 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 510k659d 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 510k659d 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, 2024approval658d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

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

    full page →eculizumab biosimilar →fda approvals ↗
    ›Oct 23, 2024approval658d agoVIGABATRIN — FDA approvalVIGABATRIN

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

    full page →VIGABATRIN →fda approvals ↗
    ›Oct 23, 2024approval658d 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 510k658d 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 510k658d 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 510k658d 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 510k658d agoVarian Medical Systems — Vitesse (5.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k658d 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 510k658d 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 ↗
    $ACBM
    $ULS
    $MMM
    $MTLS6.5600-1.06%
    $BCRX10.40+5.69%
    $AMGN414.03-0.76%
    $BSX51.32+1.70%
    $TTMI
    $SNN30.01-0.23%
    $AAPL298.01+0.70%
    $ASUR8.2700+1.35%