FDA 510(k) clearances — page 257
clearances on record, most recent first.
Clearances — page 257
25,601–25,700 of 176,542- K181400 — H. PYLORI CHEK
- K181435 — ATEC Cervical Spacer System
- K181791 — SIMPLYSTRONG, SIMPLYEZEE
- K181973 — Medtronic Model 5392 External Pulse Generator (EPG)
- K181982 — MIDAScope and Introducer Kit, and MIDASystem
- K182004 — PENTAX Medical Endoscopic Ultrasound System
- K170824 — BD Vacutainer Eclipse Signal Blood Collection Needle
- K171377 — Young INFINITY Cordless Handpiece System
- K171890 — BEXCORE Breast Biopsy System, Biopsy Needle
- K180850 — re.t.a Reuseable Tampon Applicator
- K181768 — AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
- K181968 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
- DEN170078 — Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
- K172492 — Optical Topography System ETG-4100
- K173257 — BTI Dental Implant System UnicCa
- K173509 — Biodegradable Nitrile Powder Free Examination Glove (Blue)
- K173516 — NuBorne Infant Warmer
- K173575 — OsteoReady Dental Implant System
- K173608 — Forest Dental Unit
- K173638 — Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus
- K173663 — Electronic Stethoscope DS3011A
- K173761 — Penumbra System Reperfusion Catheter JET 7
- K173773 — MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
- K173918 — VersaPAP Positive Airway Pressure (PAP) Device
- K180574 — Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor
- K180775 — Watch-PAT300
- K180943 — BioWaveGO
- K180974 — CBit Series Digital Color Doppler Ultrasound System
- K181074 — Simple Science Antimicrobial Facial and Eyelid Cleanser
- K181306 — Actifuse Flow
- K181713 — Ultraxx Nephrostomy Balloon Catheter Set
- K181767 — Cios Select
- K181923 — Quantum Workstation 12.1
- K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
- K181943 — OSCAR (OSCAR Prime, OSCAR Classic)
- K181966 — SmartPerfusion
- K181983 — PreXion 3D Excelsior
- K173454 — Multi-parameter Patient Monitor, models C30
- K180077 — NeuroQ 3.8
- K180522 — IGTFusion
- K180619 — Bongo
- K181020 — Cytosponge Cell Collection Device
- K181206 — GentleCath Glide Intermittent Urinary Catheter
- 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 +3 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.