FDA 510(k) clearances — page 321
clearances on record, most recent first.
Clearances — page 321
32,001–32,100 of 175,699- K160832 — Penumbra Smart Coil
- K151527 — Arthrex Univers Revers CA Heads and Adapters
- K153194 — VASOVIEW HemoPro Endoscopic Vessel Harvesting System
- K153638 — Bicortical Fixation Screw & Washer Nut System
- K153648 — Microcyn Plus Skin and Wound Hydrogel
- K153694 — Icare ic100
- K153698 — LumenR Tissue Retractor System
- K160126 — AIRO Computed Tomography (CT) X-ray System
- K160674 — Fujifilm Sonosite Vevo MD Imaging System
- K152563 — Pulse Oximeter (MD300M/MD300K2)
- K153192 — Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
- K142263 — Applanation Tonometer
- K150372 — VERASENSE Knee System
- K150476 — Spectra S1Plus and Spectra S2 Plus
- K151120 — Simple T Pediatric Nasal Mask
- K151731 — Rainbow Paste Stain
- K151855 — SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber
- K151874 — BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal
- K151922 — StimSox(TM) System
- K152075 — VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
- K152590 — ACCU NEWS Drug Screening Test Card/Urine Cup
- K153222 — Leva Spacer System
- K153343 — MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit
- K153361 — Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
- K153501 — Bullfrog Micro-Infusion Device
- K153624 — Neodent Implant System
- K153655 — Accuryn Monitoring System
- K160195 — Forma System, Forma Light System
- K160749 — CRIT-LINE III Blood Chamber II
- K160788 — RIOScan (RPS500)
- K160792 — Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
- K143477 — Nitrile Patient Examination gloves, Powderfree, Blue color
- K143605 — Nutraseb Facial Cream
- K152111 — Symmetry Surgical Quad-Lock Container System
- K152364 — uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
- K152959 — Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes
- K153251 — Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff
- K153696 — Chattanooga Revolution Wireless
- K160346 — MX30N(MX30TQS)
- K160348 — CX30N (CX30PQX)
- K160716 — The Nanostim Introducer Kit
- K160968 — iPulse SmoothSkin Gold Hair Removal Device
- K143578 — SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer
- K151608 — 4plus6Line Abutment System
- K151704 — Diplomat® Spinal System
- K151953 — A&D Medical TM-2657 Family of Digital Blood Pressure Monitors
- K152329 — Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System
- K152538 — JRP Wound Spreader
- K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
- K153061 — Juno VPAP ST-A
- K153174 — Ketac Universal Aplicap
- K153255 — Aero Chrome* Breathable Performance Surgical Gown
- K153419 — NuVasive CoRoent Thoracolumbar System
- K153653 — DICOM Viewer
- K160021 — Varian Sterilization Boxes
- K160608 — NormaTec Pulse and NormaTec Pulse Pro
- K160693 — Neptune E-SEP Smoke Evacuation Pencil
- K150921 — Orbit Infusion Set
- K151977 — icotec Pedicle System
- K152107 — HealthChek Network Health Station
- K152430 — All Poly Tibial Component
- K152794 — Cytosponge Cell Collection Device
- K153229 — Superbium
- K153753 — TelioCAD Multi
- K160376 — EndoSize
- K160461 — Arthrex iBalance BiCompartmental Arthroplasty System
- K160517 — ARIES System
- K152013 — QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
- K152056 — Winco Model S550 Stretchair
- K152454 — HemiCAP MTP Resurfacing Hemi-Arthroplasty System
- K152581 — LifeGlobal Micro Tips
- K152836 — TREFOIL System
- K152995 — BioMonitor 2-AF, BioMonitor 2-S
- K153043 — Noris Medical MBI Dental Implant System
- K153377 — Hoffmann LRF (Limb Reconstruction Frame) System
- K160390 — Map-it Diagnostic Mapping Catheters
- K143612 — LifeCare PCA Infusion System
- K151909 — Noris Medical Zygomatic Dental Implant System
- K152184 — MagView BIOMAGNETOMETER SYSTEM
- K152305 — Nihon Kohden Afib Detection Program QP-039P
- K153063 — PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM
- K153084 — Nephros S100
- K153098 — KLOCKNER VEGA DENTAL IMPLANT SYSTEM
- K153301 — Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
- K153305 — EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear
- K153411 — 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece
- K153444 — Philips Multislice CT System with Low Dose CT Lung Cancer
- K153446 — OLYMPIC Posterior Spinal Fixation System
- K153464 — FDR D-EVO flat Panel Detector System
- K153581 — Bladder Scanner
- K153622 — First Ray Internal Bone Staple System
- K153639 — OneQ-SL s-Clean Implant System
- K153766 — Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
- K160093 — RayStation
- K160223 — VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter
- K160266 — ICONACY(TM) I-Hip(TM)
- K160299 — geko(TM) Plus R-2 Neuromuscular Stimulator
- K160407 — spineEOS
- K160579 — Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
- DEN150028 — PneumoLiner
Data sourced from openFDA. This site is unofficial and independent of the FDA.