FDA 510(k) clearances — page 249
clearances on record, most recent first.
Clearances — page 249
24,801–24,900 of 175,699- K181909 — Luminelle DTx Hysteroscopy System
- K173703 — Sonata Sonography-Guided Transcervical Fibroid Ablation System
- K180428 — Stat Profile Prime Plus Analyzer System
- K181289 — Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System
- K181308 — SuperGrow 272, Ultimate 272
- K181347 — Aries® Lumbar Interbodies
- K181359 — InterActive SMARTBase Abutments
- K181407 — Artis zee/zeego & Artis Q/Q.zen
- K181500 — BRILLIANT Crios
- K181592 — RAIN Sheath Transradial
- K181676 — Mini Ridge Filter and auxiliary functions for PROBEAT-V
- K181711 — BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
- K173620 — Mag Vita TMS Therapy System w/Theta Burst Stimulation
- K180131 — Vicks RapidRead Digital Thermometer
- K181414 — uCT 530, uCT 550
- K181792 — Duo Lumbar Interbody Fusion Device
- K181977 — WiScope Digital Endoscope System
- K182067 — PleuraFlow System with FlowGlide Extra Drainage Length
- K173123 — Pulse Oximeter
- K173498 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
- K173549 — BIAFINE
- K180539 — Deformity Analysis and Correction Software (DACS) and Instrumentation
- K180962 — KLS Martin Individual Patient Solutions
- K180990 — TirboLOX-L Lumbar IBFD
- K181318 — ONIS-PACS
- K181593 — Vantage Galan 3T, MRT-3020/A7, V5.0
- K181978 — Zenius, Iliad and Kora Spinal Fixation Systems
- K173248 — CARDIOSKIN
- DEN170052 — Natural Cycles
- K170110 — Diana Medication Transfer Set
- K180234 — physiQ Heart Rhythm Module
- K180644 — Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
- K180814 — CoreLink® M3 Stand-Alone Anterior Lumbar System
- K180834 — Altrix Precision Temperature Management System
- K181130 — Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
- K181151 — GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
- K181253 — Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup
- K181584 — Redi-Spine
- K181627 — Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
- K181849 — iStim S2 OTC Pain Relief TENS
- K181891 — Portable X-ray System (Model: MiniX-V, Mini X-S)
- K171245 — Presygen/si-1
- K173407 — VT - 100, VT - 200
- K173505 — FORA GTel Blood Glucose Monitoring System
- K173819 — MyPlant II Implant System
- K173844 — Titan Ag 200
- K180417 — Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use
- K180759 — SECULOK Suture Anchor
- K181430 — LENSAR Laser System - fs 3D (LLS-fs 3D)
- K181533 — EVOS Wrist Fracture Plating System
- K181544 — Anchor Bolt (as an accessory to Depth Electrodes)
- K181557 — INFINITY Total Ankle System
- K181677 — Kodiak Spinal Fixation System
- K181680 — ICONN Answer II Suture Anchor
- K181866 — MotoCLIP/HiMAX Step Staple Implant System
- K172508 — Ageless Health Medical Digital Thermometer
- K173193 — F&P SleepStyle
- K180169 — EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length
- K180221 — Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs
- K180598 — UNIQA Dental Implants System
- K180734 — SmartLinx Vitals Plus Patient Monitoring System
- K180805 — Pure EP
- K181041 — 7D Surgical System Cranial Application
- K181836 — 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters
- K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader
- K181946 — Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL
- K173848 — Model WP-3840 and WP-3040
- K180248 — VascuEase IC-1200-WH
- K180351 — EndoWrist Mercury Bipolar Grasper
- K180634 — Surgical Silver Post Operative Dressing
- K181218 — AlignRT Plus
- K181234 — Self-adhesive Electrode
- K181828 — Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile
- K181962 — CubeVue
- K173845 — Arthrex SwiveLock
- K180075 — MINUET LCD, MINUET LCD eco
- K180853 — EP Granules BVF
- K181346 — CystoSure Plus Catheter
- K181217 — VesoFlow Lite DVT Compression Device
- K181425 — APTUS® Proximal Humerus System
- K163578 — EasyTouch Safety Pen Needle
- K171435 — VirtuOst Vertebral Fracture Assessment
- K172280 — BH Sterilization Pouch
- K173461 — ECG recorder and Arrhythmia Detector
- K180155 — Arm Type Blood Pressure Monitor
- K180341 — FUJIFILM 600 Series Endoscope EG-600WR v2
- K180777 — K2M Expandable Interbody System
- K180825 — Fluent Fluid Management System
- K180907 — HORIZON TMS Therapy System
- K181146 — ASK System
- K181149 — Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
- K181197 — PHMB Foam Wound Dressing
- K181219 — OptiPillows EPAP Mask
- K181237 — Glidesheath Slender Tibial Pedal Kit
- K181323 — Atlas Gold PTA Dilatation Catheter
- K181479 — Ingenia Ambition S and Ingenia Ambition X
- K181549 — Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)
- K181796 — FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions
- K181797 — Philips CT Big Bore Sliding Gantry Configuration
- K181809 — GRYPHON® Anchors with DYNACORD Suture
Data sourced from openFDA. This site is unofficial and independent of the FDA.