FDA 510(k) clearances — page 2
clearances on record, most recent first.
Clearances — page 2
101–200 of 175,620- DEN250034 — Claria System
- K252243 — Fastplex BCR-ABL (p210) %IS digital PCR Kit
- K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
- K253463 — ILR ECG Analyzer (IM007)
- K253704 — iPredict-DR
- K253884 — Koios DS (3.8)
- K260527 — FACE4D Aligner
- K260528 — OncoStudio
- K260596 — Collagen Wound Powder
- K260755 — OptraSCAN System
- K261129 — OrthoFit
- K261587 — Insufflation Retention Device (IRD) (11173-325-101)
- K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter
- K261847 — iTero Lumina Pro
- K261867 — Xpert Carba-R
- K261880 — FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01
- K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology
- K252483 — Enteral Syringe (20ml, 60ml)
- K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy
- K253434 — OSSTM Orthopedic Salvage System
- K253527 — Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)
- K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)
- K260556 — Veritas Shoulder System
- K261021 — EasyWhip Family
- K261054 — RibPlate System
- K261147 — Neodent Implant System - NeoConvert Fit
- K261473 — Chromix
- K261474 — DENTCA Tru Flexible
- K261485 — Tetric plus Fill;Tetric plus Flow
- K261852 — OTS Hip
- K261889 — Trevo Trak 21 Microcatheter
- K262228 — Transcend Bulk Fill Flowable Composite
- K253767 — UB ERP System
- K260576 — MeVis AVM Contour
- K261068 — Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)
- K261101 — Ceribell Monitor
- K261119 — NorthStar Mapping System (MAP01 or MAP01-01)
- K261808 — ISAAC Neurovascular Navigation Catheter
- K262195 — Dandy Ceramic Stain and Glaze
- K251492 — Irrigation Tubing Bipolar Cord Set
- K253484 — LUTRONIC GENIUS
- K253628 — Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)
- K253969 — ADAS 3D
- K254149 — Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)
- K260667 — Alturion Series Diagnostic Ultrasound System
- K260918 — Zolid Lunaris
- K261052 — LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)
- K261415 — Injectable Root Canal Sealer (KP-Root SP)
- K261461 — Omnipod 6 algorithm
- K261481 — Pangea Femur Reconstruction System
- K253301 — BraiN20® (BraiN20)
- K253390 — SOMNUM (SOMNUM)
- K261122 — MIST IC
- K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
- K253306 — BioTracker 2.0
- K253316 — PhAST instrument and PhAST Blood Culture Gram-negative Panel
- K253921 — VERTICALE® Navigation Instruments
- K254232 — ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)
- K260018 — Arthrex FiberButton
- K260061 — BioHorizons CEREC Compatible Ti-Bases
- K260412 — TENS 7000 Rechargeable 4 Channel (TENS 7000H)
- K260714 — MammoScreen® (5)
- K261039 — i-STAT Crea cartridge with the i-STAT 1 System
- K261253 — Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)
- K261351 — SALGINA 2.5mm Distal Radius System
- K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
- K261455 — Arterial Pressure Monitoring Set/Tray
- K261745 — LightningWire Transseptal Puncture System (TPS)
- K251188 — UNIQA® Dental Implants System
- K252584 — Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)
- K253216 — IntraOp Alignment System; CONTOUR3D Bending System
- K253274 — BedDot (G1)
- K253330 — A5 Anesthesia System (A5); A7 Anesthesia System (A7)
- K253367 — EliA CTD 13 Screen
- K253384 — mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)
- K253386 — DVT Garment
- K253394 — Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture
- K253786 — syngo.CT Coronary Cockpit
- K254108 — Jabra Enhance Select Self-fit (Jabra Enhance Select 550)
- K260231 — MiPACS V5 (1.0.0)
- K260480 — VELYS Robotic-Assisted Solution
- K260709 — ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)
- K260790 — G-Series Grind Guard
- K260809 — Arthrex Sterile VAL and VAL KreuLock Compression Screw System
- K260992 — iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)
- K261025 — Wearable breast pump (QY-101, QY-102, QY-108)
- K261242 — SimplGuide
- K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System
- K251929 — SilverCeuticals® Antimicrobial Wound Gel
- K252117 — Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
- K253263 — ConvaVAC Negative Pressure Wound Therapy System
- K253393 — Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019
- K253404 — CLEAR Aspiration System
- K253560 — Enhanced Boundary for PCCT
- K260394 — Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)
- K260669 — Endoform Dermal Template
- K260937 — Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)
- K260998 — Ceribell Neurology Review Software
- K261023 — Microdacyn Wound Irrigation Solution
Data sourced from openFDA. This site is unofficial and independent of the FDA.