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3,516 catalysts · 4,728 grant · 3,603 8k filing · 3,516 device 510k · 2,903 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2025-03-17×clear all
type
  • grant4,728
  • 8k filing3,603
  • device 510k3,516
  • approval2,903
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall883
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Mar 17, 2025

    50
    ›Mar 17, 2025device 510k532d agoCarlsmed, Inc. — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k532d agoCranial Technologies, Inc. — DOC Band 3D (510k cleared)Q/C TECHNOLOGIES, INC.

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k532d agoLagis Enterprise Co., Ltd. — LAGIS Suction Irrigation System (510k cleared)Cre8 Enterprise Ltd

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k532d agoServ Medical Pte., Ltd. — SERV MEDICAL CDSS (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k532d agoDia Imaging Analysis, Ltd. — LVivo Software Application (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k532d agoJiale Health Technology Shenzhen Co., Ltd. — Air Compression Leg Massager (K-705) (510k cleared)Aimei Health Technology Co., Ltd.

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k532d agoThe Magstim Company Limited — Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k532d agoOrthonovis, Inc. — BPS Wrist Fracture System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k532d agoGe Medical Systems, LLC — SIGNA Prime Elite (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k532d agoZiehm Imaging GmbH — Ziehm Solo FD (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k532d agoSpecialty Water Technologies, Inc. — UPT Series Medical RO Water Treatment System (510k cleared)WATTS WATER TECHNOLOGIES INC

    Product code: FIP. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k532d agoCentervue S.P.A. — MAIA (AHMACME001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k531d agoKlarity Medical & Equipment (GZ) Co., Ltd. — Klarity SGRT System (ARSG-E1A, ARSG-E3A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k531d agoWhip Mix Corporation — Hard Splint & Thermo-Adaptive Splint (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k531d agoOsteoCentric Technologies — The OsteoCentric Bone Plate and Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k531d agoIray Imaging Technology (Haining) Limited — Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k531d agoShenzhen Perfect Idea Technology Limited — Aglaia LED Beauty Device (BP-D2309) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k531d agoTeleflex Medical — QuikClot Control+ Hemostatic Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k531d agoVy Spine, LLC — FortiVy™ OsteoVy™ Lumbar IBF (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k531d agoBetter Care Plastic Technology Co., Ltd. — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k531d agoGlobal Healthcare SG Sdn. Bhd — CarbonCool® System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k531d agoOlympus Medical Systems Corp. — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k531d agoRadlink, Inc. — Radlink GPS Pro Imaging (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k531d agoHangzhou Laihe Biotech Co., Ltd. — LYHER® Oral fluid Multi-Drug Test Kit (Cube) (510k cleared)Hangzhou DAC Biotech Co Ltd

    Product code: DJC. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k531d agoQuibim S.L. — QP-Prostate® CAD (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoNanosonics Limited — CORIS System (510k cleared)

    Product code: SEW. Advisory committee: General Hospital. Type: Direct

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoGigaalaser Company , Ltd. — Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoCoreline Soft Co., Ltd. — AVIEW (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoCampomats S.R.L. — 1NEED Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoTyber Medical, LLC — Tyber Medical Anatomical Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoShenzhen Yang WO Electronic Co., Ltd. — IPL Hair Removal Device (BE965A, BE965B, BE965C) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoPeek Health, S.A. — PeekMed web (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoDRTECH Corporation — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoMacromedics BV — DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoOlympus Medical Systems Corporation — Luer-Split MAJ-2092 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoTriMed, Inc. — TriMed Ankle Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoTriMed, Inc. — TriMed Elbow and Forearm System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoMustech Electronics Co., Limited — IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoShenB Co., Ltd. — Sunny (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoScivita Medical Technology Co., Ltd. — Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoAcurable Limited — AcuPebble Ox (200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k530d agoSafesource Direct, LLC — SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k529d agoHangzhou AGS MedTech Co., Ltd. — Endoscopic Water Pump (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k529d agoHunan Haipuming Technology Co., Ltd. — HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k529d agoBoston Scientific — iSLEEVE Introducer Set (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k529d agoCardiovia , Ltd. — ViaOne Epicardial Access System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k529d agoDRTECH Corporation — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k529d agoSpectrawave, Inc. — Starlight Imaging Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k529d agoPixee Medical — Knee+ (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k529d agoAvatar Medical — brAIn™ Shoulder Positioning (510k cleared)

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

    full page →fda device 510k ↗
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