FDA 510(k) clearances — page 171
clearances on record, most recent first.
Clearances — page 171
17,001–17,100 of 175,699- K203364 — MDPC-8127
- K203701 — Locator Overdenture Implant System
- K210235 — Verrata PLUS Pressure Guide Wire
- K210338 — Edge Insulated Blade Electrode
- K210539 — CoreLink Midline Fixation System
- K210808 — Instylla Microcatheter 1.2
- K201127 — DEFEND Ear-loop Face Masks
- K201138 — AMSure® Single Use Saline Topical Solution
- K202617 — Metapex Plus
- K202992 — BriefCase, RIB Fractures Triage (RibFx)
- K203390 — Artimes pro Balloon Dilatation Catheter
- K203449 — F&P Visairo NIV Mask Range
- K210493 — CX30N (CX30PQX)
- K210752 — HydroMARK Breast Biopsy Site Marker
- K210754 — Cannulated Fasteners and Nuts
- K202136 — IDS Cortisol
- K202884 — SR-1 Skin Treatment System
- K202906 — EndoPilot2
- K203500 — RetCam Envision
- K210088 — 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes
- K210197 — NFC-600 Automated Portable Retinal Camera
- K210658 — Volition Plating System
- K210764 — Flyte
- K200919 — Idys ALIF 3DTi
- K202679 — Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3
- K203210 — Invacare Platinum 5NXG Oxygen Concentrator
- K203751 — OMNIVision system
- K210087 — Athena Surgical RMUS System
- K210436 — Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere
- K210456 — Ligament Staple
- K210629 — SecurAcath
- K210900 — Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
- K191479 — Velocity Alpha Highspeed Surgical Drill System
- K202761 — Medical Surgical Mask (Non-sterile)
- K203012 — Surgical Mask
- K210018 — Disposable Medical Mask
- DEN200055 — GI Genius
- K193630 — hekaDrill
- K201563 — PuRE PMMA Disc
- K201903 — Electric breast pump (Models: RH-228 and RH-338)
- K202084 — DeepLook PRECISE
- K202325 — EasyPoint Blood Collection Plus
- K202513 — Disposable Medical Face Mask-Model FM-04
- K202748 — Enteral Feeding Catheter
- K203000 — KeyPrint KeySplint Hard
- K203571 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
- K203681 — RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
- K203742 — IdentiTi ALIF Standalone Interbody System
- K210068 — HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System
- K210162 — Endoscope Model EI-740D/S
- K210418 — HYPER Focus
- K210710 — PENTAX Medical Video Duedenoscope ED34-i10T2
- K202134 — Well Lead All Silicone Foley Catheter with Temperature Sensor
- K202632 — Electric wheelchair (S7204/S7205)
- K202729 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K202785 — Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System
- K203550 — ActivSight Intraoperative Imaging System
- K210062 — Mectaplug PE II
- K210408 — DePuy Synthes Variable Angle Locking Patella Plating System
- K210491 — CW120N
- K200463 — Huber Needle Infusion Set, Safety Huber Needle Infusion Set
- K203491 — PicoLO Nd: YAG Picosecond Laser System
- K203520 — Blustone Synergy Interbody Fusion System
- K210106 — Nitrile Examination Gloves
- K210182 — PANAMA Anterior Cervical Plate (ACP) System
- K210701 — CATALYS Precision Laser System
- K201257 — MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
- K201457 — Auxein Brand Vertaux 5.5 mm Pedicle Screw System
- K202703 — Vascutek Gelsoft Plus ERS Vascular Graft
- K203673 — MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)
- K203801 — Disposable Surgical Face Mask
- K210554 — Physica system
- K210681 — SiteSeal SV
- K210685 — AcQCross Qx Integrated Transseptal Dilator/Needle
- K210716 — CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
- K210734 — Endovascular Dilator and Sets
- K202655 — Disposable Medical Mask
- K203480 — DOUBLEFLO system
- K203499 — Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank
- K203567 — Oral-B Dry Mouth Oral Rinse
- K203623 — StentBoost Mobile
- K210130 — Stockert S5 System
- K210850 — ADAS 3D
- K201171 — LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable
- K201611 — Apex Knee System
- K202183 — Porcine Mineral Collagen Composite
- K202243 — SkinPen Precision System
- K202441 — Eclipse II with Smart Noise Cancellation
- K202447 — Medline Orbis Surgical Gown
- K202909 — CreoDent Solidex Customized Abutment
- K202928 — DV. Target
- K203230 — Global Shoulder and Delta CTA systems
- K203310 — SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System
- K203472 — KMTI Hip Replacement System
- K203767 — Pristine Long-Term Hemodialysis Catheter
- K203816 — DeGen Navigated Instrumentation
- K210023 — Surgical Face Mask
- K210251 — ClearPath Disposable Introducer
- K210275 — Polaris Spinal System
- K210692 — DigitalDiagnost
Data sourced from openFDA. This site is unofficial and independent of the FDA.