FDA 510(k) clearances — page 99
clearances on record, most recent first.
Clearances — page 99
9,801–9,900 of 175,620- K223339 — Bone Chamber Implant
- K230716 — Robotic Graft Delivery Instruments
- K230945 — Forma Medical Headless Compression Screw
- K211143 — Pulse Oximeter
- K213953 — BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes
- K222683 — Fibroid Mapping Reviewer Application (FMRA)
- K223252 — TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas
- K230077 — LaserME
- K230087 — POINT Kinguide Agile Hybrid Navigation System
- K230257 — Arthrex Intramedullary Nails
- K230395 — Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
- K230407 — FloNavi Open Field Fluorescence Imaging System
- K230462 — OPTIX H2 Patient Specific Instrument System
- K230558 — Revital-Ox PAA High Level Disinfectant Chemical Indicator
- K230846 — iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System
- K231441 — ARIX Ankle System
- K231456 — Avitus® DragonWing Large Volume Autograft Delivery System
- K231460 — FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System
- DEN230012 — Ruthless Spine RJB
- K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System
- K221673 — Bonafix TiBase
- K222026 — Neodent Implant System - Zirconia Implant System
- K223106 — Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
- K223173 — Proxeo ULTRA (PB-510, PB-520 and PB-530)
- K223290 — CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)
- K223791 — TalWire
- K223886 — Wearable Breast Pump (Model S18)
- K230016 — Cercare Medical Neurosuite
- K230269 — Ultraflex Tracheobronchial Stent System
- K230445 — OnX Tough
- K231041 — JiveX (Model Number / Release: 5.4)
- K231392 — NaviNetics Reusable Stereotactic System (NN1000)
- K231428 — Mobility Scooter (Models: W3431D)
- K231757 — Ez3D-i /E3
- K231782 — FlowSaver Blood Return System (80-101)
- K231841 — PathLoc SI Joint Fusion System
- K221961 — HydroMARK Plus Breast Biopsy Site Marker
- K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
- K223125 — XR90 (XR90-SYS)
- K223261 — Open Rib
- K223424 — Spine Auto Views
- K223426 — ECHELON Synergy MRI system
- K223728 — Micro Rx
- K230611 — X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)
- K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
- K230877 — Admira Fusion 5
- K231064 — ReddyPort Elbow
- K231351 — Chondral Quant
- K231438 — Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System
- K231449 — Portable X-ray System Model Ray98(P)
- K231754 — Praxiject 0.9% NaCl
- K231769 — activL® Next Generation Instrumentation
- K231833 — Biograph Vision.X and Biograph Vision.X Edge
- K223631 — Comprehensive Segmental Revision System(SRS)
- K223808 — Zavation Navigation Instrument System
- K230532 — RADx Intraoral Appliance for Snoring and Sleep Apnea
- K230823 — AusculThing ACC
- K231035 — FusedCO Algorithm
- K231241 — NanoHive Medical Lumbar Interbody System
- K231709 — AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
- K231714 — Graftys Quickset
- K221137 — Play and Joy Water-Based Lubricant
- K230307 — Dentis i-Clean System
- K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K230680 — Anthogyr Surgical Cassettes
- K230942 — SPIRA® Posterior Lumbar Spacers
- K231386 — Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
- K231528 — Bonalive Orthopedics granules
- K231711 — microINR System
- K231735 — NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System
- K231925 — MINIMA S System
- K220646 — Play&Joy InvisiLube Lubricant Capsule
- K221307 — Edge Upper Cervical System
- K222666 — X-View 3D Pan/X-View 2D Pan
- K223213 — Tandem Mobi Insulin Pump with Interoperable Technology
- K223683 — EnteraLoc Flow
- K223724 — MOZI TPS
- K231091 — AcQMap High Resolution Imaging and Mapping System
- K231312 — PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
- K231387 — Endofill
- K231412 — CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
- K231701 — Ziehm Vision RFD 3D
- DEN220058 — BT-001
- K222707 — IH Implant System
- K223382 — AeviceMD
- K223388 — Invia® Integrated Dressing
- K223448 — Bladder Scanner Model: BVT02
- K223578 — T3 Platform software
- K230080 — Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood
- K230804 — Complement Kit Cases
- K230932 — ANDORATE® Valve Kit
- K231253 — Overture Orthopaedics Patellofemoral System
- K231318 — Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
- K231668 — Spine CAMP (1.1)
- K231844 — ProMIS Fixation System
- K232011 — Cleo
- K221056 — ARGUS PB-3000
- K222220 — SpinMedix Absorbable Fibrous Membrane
- K223747 — Whitsundays Mask System
- K223780 — Lumos 3DX
Data sourced from openFDA. This site is unofficial and independent of the FDA.