FDA 510(k) clearances — page 312
clearances on record, most recent first.
Clearances — page 312
31,101–31,200 of 175,699- 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)
- K160563 — Fully Automatic Electronic Blood Pressure Monitor
- K160685 — Surveyor S4 Mobile Monitor
- K161006 — Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
- K161286 — IPL Therapy Machine
- K161387 — Mont Blanc and Mont Blanc MIS Spinal Systems
- K161798 — FacetBRIDGE® System
- K161986 — SIDEKICK and USHER Support Catheters
- K151542 — A-Oss
- K151750 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile
- K151757 — IMMEDIATELOAD Dental Implant System
- K160219 — Hilal Embolization MicroCoils
- K160284 — JointPoint
- K160636 — iPEP System and vPEP
- K160774 — IonoStar Plus
- K161033 — AFX Femoral Implant With Inserter
- K161234 — CASSI II Rotational Core Biopsy System
- K161289 — DURAFIBER Ag
- K161505 — DyeVert NG Contrast Modulation System
- K151824 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
- K160467 — Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
- K160542 — 5.0 Fr Arndt Endobronchial Blocker Set
- K160675 — Powder free vinyl patient examination glove, colored (yellow)
- K161220 — ARIES® Flu A/B & RSV Assay
- K161409 — M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem
- K161864 — ARIX Foot System
- K161896 — Biomet Microfixation Sternal Closure System
- DEN140040 — Nautilus BrainPulse 1000
- K153065 — The Hammertoe Correction System
- K153205 — IDSS ForceTriad Control Module
- K153352 — Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System
- K160275 — Fuse Endoscopic System with FuseBox Processor
- K160414 — Precision Point Biopsy Needle Guide
- K160664 — Aqueduct 100 Cervical Dilator
- K160699 — VIRTU Lumbar Spacer System
- K160856 — SpineView X-Pac Expandable Lumbar Cage System
- K160932 — 8ch Foot Ankle Coil
- K160937 — Senolris
- K160938 — SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens
- K160999 — Infra-red forehead thermometer
- K161199 — EndyMed Contour Handpiece
- K160961 — Mozec NC-Rx PTCA Baloon Dilatation Catheter
- K161427 — Pirouette 035
- K152087 — HeatLux Pro II
Data sourced from openFDA. This site is unofficial and independent of the FDA.