FDA 510(k) clearances — page 108
clearances on record, most recent first.
Clearances — page 108
10,701–10,800 of 176,479- 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 +5 more
- 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
- K223806 — VERTICALE® Triangular Fixation System
- K230173 — Servo-air Lite Ventilator System
- K230510 — MyEllevate
- K230968 — VYBE RF Electrosurgical System
- K231003 — Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
- K231339 — Tyber Medical Pin and Wire System (various)
- K231568 — HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
- K220980 — Tissue Approximation System (TAS)
- K221058 — LungTrainer (MD2 & MD3)
- K222015 — Integral Titanium Cervical Interbody
- K230001 — Electric Scooter (Model: M2020)
- K230864 — VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin
- K231279 — Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm
- K231358 — Universal Seal (5-12 mm)
- K231641 — Rotium Bioresorbable Wick
- K231740 — MemorialTM Gloves
- K221664 — CLEARinse CTS Specimen Collection and Transport System
- K222745 — Axial3D Insight
- K230025 — IVYLASER Handhold Hair Removal Machine
- K230487 — Dental Lithium Disilicate Glass-Ceramic
- K230569 — Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ) +1 more
- K230720 — LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
- K230901 — Premier HpSA Flex (619096)
- K231280 — CarboClear® X Pedicle Screw System +2 more
- K231653 — BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter
- K230725 — NB Implant System
- K212409 — Ulspira TS Nitric Oxide Therapy System
- K213253 — Pixyl.Neuro
- K221294 — preCARDIA Occlusion System
- K222466 — AirTom
- K223135 — AblatePal Radiofrequency Ablation System
- K223374 — Blood Pressure Monitor
- K223694 — Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)
- K223854 — Unistik® ShieldLock, Unistik VacuFlip
- K230052 — Inogen Rove 6
- K230156 — 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
- K230456 — SGM Femoral Nail System
- K230469 — Compact Wearable Pump
- K230917 — FebriDx Bacterial / Non-bacterial Point of Care Assay
- K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
- K230933 — REMI Remote EEG Monitoring System
Data sourced from openFDA. This site is unofficial and independent of the FDA.