FDA 510(k) clearances — page 192
clearances on record, most recent first.
Clearances — page 192
19,101–19,200 of 176,479- K201941 — Monitor B125, Monitor B105
- K202422 — Arietta 65
- K202581 — Arthrex TightRope II
- K202624 — Z-Span Plate System
- K191940 — Palm NRG cellulite and muscle toning body device
- K200071 — Blue Beacon Submucosal Injectable Solution
- K201683 — PMMA Block
- K202198 — FlareHawk Interbody Fusion System
- K192618 — e-Motion M25
- K192904 — SpeediCath Compact Set
- K202552 — Midas Rex Attachments and Dissecting Tools
- K202558 — Ellusa Bipolar Wands
- K202562 — Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set
- K203032 — IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle
- K193296 — eCordum Cardiac Monitor (eCordum CM)
- K193421 — Smart Alarm Interface
- K200190 — ScalpelCric
- K200316 — UNiD IB3D ALIF
- K200323 — AutoContour
- K201695 — Patent Hemostasis Band (PH Band)
- K201988 — T-Lite
- K202013 — WRDensity by Whiterabbit.ai
- K202157 — PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack
- K202302 — Atlas Spine Rebar (Ti) Spacer System
- K202497 — Aulisa Multiple Patient Digital Vital Sign Monitoring System
- K202556 — HS30 Diagnostic Ultrasound System
- K202901 — Longeviti ClearFit Cranial Implant
- K202938 — Aesculap Caiman 5 Seal and Cut Technology System
- K203007 — eKuore Pro Series
- K203028 — FUJIFILM Distal End Cap
- K192282 — MedCAD® AccuPlan® System
- K192989 — Libertas E-XLPE Modular Liner
- K193090 — HCG Zirconia Ceramic Block
- K193169 — Nelson Sentinel Series Basic Chlorine Sentinel
- K193206 — WiZARD 510 Nasal Mask
- K200088 — g.Estim FES
- K200299 — Curos Jet Disinfecting Cap
- K200332 — EXPERT - Joint Fixation System
- K200425 — Female Luer Lock Cap
- K201092 — LSN
- K201692 — NuVasive Modulus XLIF Interbody System
- K202105 — OsteoMed ExtremiFix Mini & Small System Tray
- K202142 — Sleepware G3
- K202496 — ANTHEM Fracture System
- K202539 — Nutriglide(TM) Nasal Feeding Tube
- K202646 — Visera Elite II Video System Center
- K202912 — ARIX Ankle Distal Tibia System
- K202949 — CONSTRUX Mini PEEK Spacer System
- K202957 — Flexible Video Cysto-Urethroscope (C-view)
- K203058 — CloudVue
- K193038 — Comprehensive Shoulder System
- K200003 — NP1 Instrument, Creo Electrosurgical System
- K200125 — Thermoforming Sheet Materials
- K200153 — Bright Bond Universal
- K200759 — NIM Vital, Nerve Integrity Monitor
- K200790 — LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System
- K201395 — Sterile High-pressure Angiographic Syringes for single-use
- K201475 — Ultimate Contour, Ultimate Contour Mini
- K201497 — EVOS Cabling System
- K202089 — LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
- K202259 — Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip
- K202864 — Tri-Staple 2.0 Reloads
- K202935 — Syntec Femoral Nail Extended System
- K193084 — TIB Abutment System
- K200156 — Bright Low Flow
- K200273 — FREEPRINT temp
- K201627 — Dental Computed Tomography X-Ray System, Green X
- K202152 — NextAR TKA Platform
- K202519 — OrthoNext Platform System
- K202887 — IlluminOss Bone Stabilization System
- K202960 — General Cutting Contra Handpiece
- K203005 — Mazor X
- K203099 — Triathlon PKR System
- K200150 — Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)
- K200937 — ACURA Stabilization System
- K201811 — coraForce and coraFlex Support Catheters
- K202065 — DOLOMITE Anterior Cervical Stabilization System
- K202179 — Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)
- K202469 — G-EYE System
- K202489 — AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System
- K202528 — Cannulated Power Driver Attachment
- K202722 — 1212FCA
- K201335 — Li-Battery powered OTC TENS/EMS Combination Stimulator
- K192317 — Planmed Clarity 2D and Clarity S
- K192811 — BenestaTM Tissue Removal Device
- K193088 — MaxZero Extension Sets with Needle-Free Connector(s)
- K193357 — V-Mix
- K193556 — Cryocheck Hex LA
- K200109 — OXY-1 System
- K200223 — PocketDoc Micro Wound Therapy System
- K200249 — Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
- K201824 — Nerivio
- K201843 — Infrared ear and forehead thermometer, model YI-100
- K202071 — SURGIPHOR Wound Irrigation System
- K202392 — SIR-Spheres Microspheres Activity Calculator (SMAC)
- K202429 — Mobio Total Knee System
- K202797 — Drakon and Sequre Microcatheters
- K202894 — Wiltrom Spinal Fixation System
- K193623 — DIOnavi-Denture
- K200318 — UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
Data sourced from openFDA. This site is unofficial and independent of the FDA.