FDA 510(k) clearances — page 71
clearances on record, most recent first.
Clearances — page 71
7,001–7,100 of 175,620- K241178 — DEKA ACE Pump System
- K232602 — 3DMatrix Surgical Mesh
- K232603 — CamAPS FX
- K232642 — AirKEE T900
- K233108 — VinDr-Mammo
- K233120 — CWM-930S, FIXER DV9
- K233251 — NOxBOXi Nitric Oxide Delivery System
- K233868 — dima Print Teeth & Temp
- K240294 — Syngo Carbon Enterprise Access (VA40A)
- K240701 — Drill Guide; Drill Bit; Spine & Trauma Navigation
- K241134 — 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)
- K241396 — uCerv Flux-C 3D Porous Titanium Cervical Interbody
- K232655 — Bonvadis®
- K232740 — Paltop Short Implants
- K233099 — Gladiator
- K233268 — Impress Angiographic Catheter
- K233819 — Fogarty Venous Thrombectomy Catheters
- K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve
- K233884 — INUMI Flex Needle
- K240097 — Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
- K240199 — IntraOp Alignment System
- K240224 — Zenition 90
- K240456 — Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap
- K241014 — Biomet Kirschner Wires (K-Wires)
- K241100 — Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
- K241106 — Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)
- K241126 — OviTex PRS
- K241143 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- DEN230068 — 3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader 1190
- K232677 — Reia pessary
- K232759 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
- K232946 — Yumizen H2500
- K233336 — 21.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
- K233442 — troCarWash System
- K233543 — YSIO X.pree
- K240433 — ProSeal Injection Site Extended Male Luer Lock (422140)
- K240806 — Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
- K241110 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
- K223399 — AViTA Pulse Oximeter
- K232702 — Solo+ Tympanostomy Tube Device (TTD)
- K233341 — Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
- K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
- K233620 — MIM - Centiloid Scaling
- K240474 — Multi-function Platform Systems (BL-M10)
- K240511 — Dentis s-Clean SQ-SL Fixture
- K240520 — Diode Laser Hair Removal System (SH-VD910)
- K240772 — Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)
- K241252 — Disposable Vinyl Examination Gloves
- K241276 — Vector Pedicle Screw System
- DEN230035 — DentalMonitoring
- K220891 — Kahook Dual Blade Glide (KDB Glide)
- K232516 — Sentec Digital Monitoring System (SDMS) tCOM+
- K232525 — Yoni.Fit Bladder Support
- K232793 — Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
- K233209 — uOmnispace.CT
- K233215 — icotec Anterior Cervical Plate System
- K233236 — Radiance V5
- K233933 — CIRRUS HD-OCT Model 6000
- K240482 — Intense Pulsed Light System (ST-690)
- K240935 — ARENAL Anterior Cervical Plate System
- K241042 — SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
- K241175 — MiRus MoRe Lumbar Plating System
- K230711 — Pain Therapy Device(Model: P.T.S-X)
- K232495 — Sempulse Halo Vital Signs Monitor
- K232542 — Wedge XL Delivery Catheter
- K232786 — Stimulation System (PA series, PR series, S series and Q series)
- K232849 — Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
- K232933 — AirKEE P900
- K233137 — Ticare Dental Implant Systems
- K233473 — DEKA LOTUS
- K233625 — RAYDENT SW
- K233841 — HD80 Series Ultrasound Diagnostic System
- K240059 — FAgamin®
- K240328 — eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
- K240386 — Picosecond Nd:YAG Laser Systems (BL-C10)
- K240445 — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.
- K240752 — DEKA TORO
- K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)
- DEN230043 — Notal Vision Home Optical Coherence Tomography (OCT) System
- K231940 — BruxZir® NOW SRC
- K233247 — Heuron ICH
- K233985 — TRIUX neo (NM27000N ); MEGreview (SW26241N-B)
- K240278 — Full Wedge Lateralized and Augmented Baseplates
- K240368 — E3D-A Interbody System
- K241043 — Augment Off-Axis Instrument System
- K241049 — CANON Fundus Camera CR-10 (CR-10)
- K241053 — MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 800 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 1600 mL
- K241112 — BriefCase-Quantification
- K232662 — BNLE Hydrophilic Jacketed Peripheral Guidewire
- K233913 — Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)
- K240426 — Aventus Clot Management System
- K232242 — BEAR 2 Body
- K232529 — Disposable Double Lumen Endobronchial Tube
- K232614 — Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)
- K232862 — MIM Monte Carlo Dosimetry
- K233875 — Brainomix 360 e-Lung
- K240658 — 1060nm laser body slimming machine
- K240759 — REMEX-GR100
- K240949 — Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)
- K232410 — SmartChest
Data sourced from openFDA. This site is unofficial and independent of the FDA.