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597 catalysts · 3,288 8k filing · 1,642 grant · 1,000 device adverse event · 755 approval · 597 device 510k · 584 earnings

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type: device 510k×from 2026-02-10×clear all
type
  • 8k filing3,288
  • grant1,642
  • device adverse event1,000
  • approval755
  • device 510k597
  • earnings584
device pma
455
  • device recall178
  • phase 2 completion172
  • recall162
  • therapy area

    no tagged catalysts yet

    Week of Feb 9, 2026

    50
    ›Feb 10, 2026device 510k185d agoK2m, Inc. — Vulcan Spinal System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k185d agoFresenius Medical Care Renal Therapies Group, LLC — multiFlux 130 (F00013123); multiFlux 160 (F00013124) (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k185d agoOvigenex, LLC — CollOvine™ Wound Powder (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k185d agoFourth Axis, LLC — LANDR Contact LENS Case (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k185d agoShenzhen RF Tech Co., Ltd. — GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k185d agoCreoDent Hudson Valley — Solidex® Ti-Links and Screws (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k185d agoMedtronic Xomed, Inc. — NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080) (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k185d agoSiemens Medical Solutions USA, Inc. — MI View&GO (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k185d agoBiodynamik, Inc. — XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k185d agoEarflo, Inc. — Earflo (EF001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2026device 510k185d agoBoston Scientific Corporation — SpaceOAR Vue System (SV-2101) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Feb 11, 2026device 510k184d agoStryker Neurovascular — AXS Lift Intracranial Base Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2026device 510k184d agoAi4medimaging Medical Solutions S.A. — AI4CMR v2.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2026device 510k184d agoSI-BONE, Inc. — iFuse INTRA Ti™ Implant System (510k cleared)SI-BONE, Inc.

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

    full page →fda device 510k ↗
    ›Feb 11, 2026device 510k184d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2026device 510k184d ago1World Vista Medical — SteriHub™ Disinfecting Device and Protective Cover (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2026device 510k184d agoSutter Medizintechnik GmbH — CURIS II RF Generator (REF 360100-05) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2026device 510k184d agoSavfe Co. , Ltd. — ArmSure Fluoroscopic Positioning System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2026device 510k184d agoUltrasound AI — Delivery Date AI (510k cleared)

    Product code: SHE. Advisory committee: Radiology. Type: Direct

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k183d agoSZ KKS Silicone&Electronic Co., Ltd. — LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k183d agoWell-Life Healthcare , Ltd. — Well-Life Incontinence Stimulation System (WL-2405i(P)) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k183d agoXenocor, Inc. — Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) (510k cleared)Xencor Inc

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k183d agoRoche Diagnostics — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k183d agoTianjin Huahong Technology Co., Ltd. — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k183d agoGuangzhou Hehong Biotech Co., Ltd. — Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k183d agoRoche Diagnostics — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k183d agoKarl Storz SE & CO. KG — IMAGE1 (TC400US); X-to-4U Adapter (TC040) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k183d agoStryker Endoscopy — L12 LED Light Source with AIM (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k183d ago4Web, Inc. — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k183d agoMedtronic Navigation, Inc. — Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k183d agoPuracath Medical, Inc. — PuraCath Firefly Needleless Connector IT (9005) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k183d agoHealgen Scientific,, LLC — Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k183d agoMet One Technologies, LLC — Wrist Fracture System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoShenzhen Best Electronics Co., Ltd. — NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoClouds of Care — PreOp v3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoShenzhen TPH Technology Co., Ltd. — Wearable Breast Pump (Model W2) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoABBOTT MEDICAL — Armada™ 14 NC PTA Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoEndo Tools Therapeutics S.A. — Endomina EZFuse system (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoAlcon Laboratories, Inc. — DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (510k cleared)Alcon Laboratories Inc

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoLex Diagnostics Limited — VELO Respiratory Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoRetia Medical Systems, Inc. — Argos Infinity (Rev. 1.0) (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoNanoHive Medical, LLC — Hive™ Standalone Cervical System and Hive™ C Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoShenzhen Imdk Medical Technology Co., Ltd. — Wrist Blood Pressure Monitor (BPM-W1VL) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoShanghai United Imaging Healthcare Co., Ltd. — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoShenzhen TPH Technology Co., Ltd. — Wearable Breast Pump (Model W12) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoPulmonx Corporation — Chartis Precision Catheter (510k cleared)Pulmonx Corp

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoMedinice S.A. — CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoContour Research, LLC — Contour Light (CL-100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoJoytech Healthcare Co. , Ltd. — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) (510k cleared)NVP Healthcare Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 13, 2026device 510k182d agoMedela, LLC — Motion InBra (YM-8801) wearable breast pump (510k cleared)

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

    full page →fda device 510k ↗
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    $BSX51.69+0.53%
    $FRTRY
    $LUNG1.3700-3.52%
    $XNCR22.99-0.82%
    $FRTRY
    $SIBN13.41+15.55%
    $FMS23.63-0.38%
    $MMSI90.50-0.77%