FDA 510(k) clearances — page 320
clearances on record, most recent first.
Clearances — page 320
31,901–32,000 of 176,542- K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
- K161019 — Uroview FD
- K161385 — Just Like Me Personal Lubricant
- K161396 — SPEC Model M23
- K161518 — PACS CORE/ENCORE
- K161748 — SUPRIA w/guideShot Option
- K161403 — A.R.C. Laser Surgical Fibers and Probes
- K161445 — PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C
- K161502 — MC1 Plus
- K161933 — The Braun ThermoScan® 3 High Speed Compact Ear Thermometer
- K152125 — Oral Surgery System and Accessories
- K153478 — Sydney IVF Gamete Buffer
- K161037 — Tarsa-Link Stand-Alone Wedge Fixation System
- K161171 — PressureWire X Guidewire
- K161182 — Solana Trichomonas Assay
- K161292 — Distal Radius Plating System
- K162196 — Dell UP3216Q with QUBYX PerfectLum bundle
- K153089 — 'cottony' II TAPE, PLEDGETS
- K153285 — EMS-200
- K153297 — Perifix and Contiplex Catheter
- K153308 — EUROIMMUN Anti-West Nile Virus ELISA (IgM)
- K153375 — ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
- K160331 — LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp
- K160592 — SUPERCATH 6
- K160840 — ECG100+, ECG200+
- K161210 — RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
- K161269 — CELTRA Press
- K161324 — Raycell Mk2
- K161661 — Thermi RF Accessories
- K152890 — SACCADOMETER PLUS, SACCADOMETER ADVANCED
- K153283 — VivoSight Dx Topical OCT System
- K153452 — Salto XT, Salto Talaris
- K153573 — Converge
- K160138 — Adhesive Electrodes
- K160382 — OT EQUATOR
- K161266 — Athena Breast Pump
- K161267 — Response BandLoc Spinal Fixation
- K161336 — VSI StraitSet micro-introducer kit
- K161574 — Discovery MI
- K161622 — LensGiene Sterile Saline Solution
- K161791 — Aer-O-Scope Colonoscope System
- K162075 — NICO TRIOwand
- K162077 — Laparoscopic Spray Applicator with Spinning Luers
- K152834 — Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
- K153303 — EUROIMMUN Anti-West Nile Virus ELISA (IgG)
- K160147 — CT TrueView
- K160239 — TAP 3, TAP 1
- K160472 — Hidrocor, Hidrocharme, and Natural Colors
- K160516 — Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths
- K160565 — Fully Automatic Electronic Blood Pressure Monitor
- K160648 — MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
- K161066 — SpotLight CT
- K161100 — Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses
- K161240 — Rhythm View Workstation (non-streaming)
- K161575 — Affirm Lateral Arm Upright Biopsy Accessory
- K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose
- K161955 — 5D Viewer
- K152135 — Quantitative Electrocardiographic Detector (QED 2000)
- K152224 — Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)
- K153200 — SnoreRx
- K153596 — ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
- K160787 — Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet
- K161026 — NexSite HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)
- K161148 — icobrain
- K161914 — Genesys Spine TiLock Cortical Spinal System
- K153678 — PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
- K153709 — Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet
- K153742 — Apollo Balloon Dilatation Catheter
- K160611 — P-ARTIS
- K160679 — WoundClot9
- K160743 — Philips Ingenuity CT
- K161278 — Cerafix Dura Substitute
- K161306 — BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
- K153276 — da Vinci Xi Surgical System
- K161985 — Steerable Guide Catheter
- K160097 — Image Fast Set, Image Regular Set
- K160248 — ArgenIS Titanium Abutments
- K160338 — Triton System
- K160483 — Burn-out Cylinder and Angled Screw Abutments
- K160806 — Verza Guidance System
- K160865 — Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso
- K161113 — QXLink
- K161224 — LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3
- K161245 — EP-TRACER System
- K161683 — SYSTEM 1E Liquid Chemical Sterilant Processing System
- K161706 — Vivid iq
- K161867 — On Call Pro Blood Glucose Monitoring System
- K161877 — Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl
- K152471 — CAPO BULK FILL
- K153209 — RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply
- K153243 — Fehling-Punches
- K153274 — Med-Tainer Single Deposit Container
- K153329 — MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis
- K153540 — Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
- K153549 — OSSIX VOLUMAX
- K153551 — ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.
- K153744 — A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)
- K153756 — Microlyte Ag
- K160281 — OSSIX PLUS
- K160560 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
Data sourced from openFDA. This site is unofficial and independent of the FDA.