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3,575 catalysts · 4,728 grant · 3,603 8k filing · 3,575 device 510k · 2,937 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2025-03-10×clear all
type
  • grant4,728
  • 8k filing3,603
  • device 510k3,575
  • approval2,937
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall891
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Mar 10, 2025

    50
    ›Mar 10, 2025device 510k539d agoImplantcast GmbH — AGILON® XO Shoulder Replacement System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k539d agoIntuitive Surgical, Inc. — da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k539d agoMedtronic Neurosurgery — Duet External Drainage and Monitoring System (EDMS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k539d agoSurgical Instrument Service and Savings, Inc. — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k539d agoExactech, Inc. — Alteon® HA Femoral Stems (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k539d agoVaporox, Inc. — Wound Treatment System (VHT-200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k538d agoIconocare Health — 8mm Monopolar Curved Scissors (470179) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k538d agoStryker Instruments — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k538d agoDeka Research & Development Corp. — RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (510k cleared)UNITED THERAPEUTICS Corp

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k538d agoArthrex, Inc. — Arthrex TightRope Soft Button, RT (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k538d agoDisa Medinotec — OutFlo Aortic Valve Dilatation Balloon Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k538d agoBetter Diagnostics AI Corp. — Better Diagnostics Caries Assist (BDCA) Version 1.0 (510k cleared)CS DIAGNOSTICS CORP.

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k538d agoSignature Orthopaedics Pty, Ltd. — Origin™ TT Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k537d agoRewalk Robotics Ltd. Dba Lifeward — ReWalk® 7 Personal Exoskeleton (50-20-0005) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k537d agoCutting Edge Spine, LLC — EVOL® ha – Hyper C Cervical Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k537d agoShenzhen Zuowei Technology Co., Ltd. — Walking rehabilitation training electric wheelchair (ZW518) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k537d agoQuantalx Neroscience — Delphi Amplifier (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k537d agoChangsha Anxiang Medical Technology Co., Ltd. — Wireless TENS & EMS Unit (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k537d agoRay Co., Ltd. — RCT600 (510k cleared)Ray Therapeutics Inc

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k537d agoRayence Co., Ltd. — 2430TCA with Xmaru W (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k537d agoWontech Co., Ltd. — PICOALEX (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k537d agoDannik, LLC — DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k537d agoBiofire Defense, LLC — BioFire Warrior Panel; BioFire Warrior Panel Control Kit (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k536d agoBioserenity Medical Devices Group — IceCap product line (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k536d agoBoston Aesthetics, Inc. — 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k536d agoMedcad — MedCAD® AccuStride™ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k536d agoMY01, Inc. — MY01 Continuous Compartmental Pressure Monitor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k536d agoZiehm Imaging GmbH — Ziehm Vision FD (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k536d agoSioxmed, LLC — SiOxC Cream (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k536d agoCryosurgery, Inc. — CryoFreeze Wart and Skin Tag Remover (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k536d agoXemis Medical Technology (Shenzhen) Co., Ltd. — Photon Therapy Apparatus (BL-10) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k536d agoMaxx Orthopedics, Inc. — Freedom Total Knee System (All-poly Tibial Plate) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k536d agoInari Medical, Inc. — FlowTriever2 Catheter (510k cleared)Mobia Medical, Inc.

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k536d agoAugmedics, Ltd. — xvision Spine system (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k536d agoSurgify Medical OY — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k536d agoG.N.S Neolaser , Ltd. — neoLaser Laser Surgery Fibers (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k536d agoSpectranetics — Turbo-Elite Laser Atherectomy Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k535d agoOrthoPediatrics Corp. — VerteGlide Spinal Growth Guidance System (510k cleared)ORTHOPEDIATRICS CORP

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k535d agoAion Biosystems, Inc. — AION TempShield™ (510k cleared)NED Biosystems Inc

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k535d agoShenzhen Sanping Image Technology Co., Ltd. — Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k535d agoDosisoft SA — PLANET Onco Dose (3.2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k535d agoCenters for Disease Control and Prevention — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) (510k cleared)Hubei Provincial Center for Disease Control and Prevention

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k535d agoNexxt Spine — NEXXT MATRIXX® SI System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k535d agoArrow International, LLC (A subsidiary of Teleflex, Inc.) — Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) (510k cleared)Arrow International LLC

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k535d agoAidite (Qinhuangdao) Technology Co., Ltd. — Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k535d agoKettenbach GmbH & Co. KG — Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k535d agoKorot Co., Ltd. — KOROT Blood Pressure Monitor (KOROT P3 Accurate) (510k cleared)Kowa Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k535d agoLumea, Inc. — Viewer+ (510k cleared)

    Product code: QKQ. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k535d agoBaxter Healthcare Corporation — Solution Administration Sets (510k cleared)Baxter Healthcare Corp

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k535d agoArthrex, Inc. — Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
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    $UTHR515.46-2.36%
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