FDA 510(k) clearances — page 88
clearances on record, most recent first.
Clearances — page 88
8,701–8,800 of 175,620- K231440 — Combo Electrotherapy Device
- K231569 — ManaFlexx 2 (model: MF002-RX, MF002-OTC)
- K231586 — Endophys Blood Pressure Monitor model BPM-30
- K231918 — Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter
- K231955 — aprevo® Digital Segmentation
- K232113 — Halcyon, Ethos Radiotherapy System
- K232186 — LOGIQ e
- K232251 — APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension
- K232266 — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K232380 — t:slim X2 Insulin Pump with Interoperable Technology
- K232382 — Control-IQ Technology
- K232742 — Arthrex FiberTak Suture Anchor
- K233428 — Easycess Aspiration Pump
- K230326 — ENFit to ENFit Extension Sets
- K230800 — XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
- K232029 — VersaWrap Nerve Protector
- K232076 — Fibercure
- K232176 — STELLAR Knee
- K232345 — ATEC Posterior Navigated Disc Prep Instruments
- K232532 — Nd:Yag Laser Therapy Systems
- K232725 — Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
- K233056 — EpiZact
- K233062 — BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
- K233407 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)
- K233518 — BASE290 LED Curing Light
- K230927 — OptiMesh Multiplanar Expandable Interbody Fusion System
- K231414 — CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
- K232730 — Aventus Thrombectomy System
- K232880 — Inzii Ripstop Redeployable Retrieval System
- K233402 — Bard 3DMax Mesh
- K233502 — TERA HARZ II
- K230083 — SAFIRA
- K230328 — Speedboat Flush SB1 Instrument
- K230352 — Tornier Humeral Nail and Tornier Long Humeral Nail
- K230602 — Hudson RCI® TurboMist Nebulizer System
- K230814 — VRNT
- K231238 — Ultravision2 System
- K231243 — Finger Clip Pulse Oximeter
- K231298 — Ultravision2 System Integrated Monopolar L-Hook (H/S)
- K231362 — OCS Heart Leukocyte Depleting Filter
- K231629 — 091 Balloon Guide Catheter
- K231868 — Electric Wheelchair (Robooter E40), Model name: BBR-E40-01
- K231947 — EVOLUTION® Cement Keel
- K232099 — Neodent Implant System - GM Zygomatic Implant System
- K232294 — HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One)
- K232310 — Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml
- K232318 — VICTORY Lumbar Plate System
- K232321 — FlexCath Contour Steerable Sheath
- K233320 — LINQ II Insertable Cardiac Monitor (LNQ22)
- K230457 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
- K230755 — NuEra Tight RF Model OptiStream
- K231029 — Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
- K231222 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
- K231340 — Renova Spine Balloon Catheter
- K231378 — Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0
- K231836 — ClariVy Cervical IBF System
- K231874 — AOT & T-L Abutment
- K231965 — Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
- K232145 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System
- K232751 — BriefCase-Triage
- K232280 — NextAR TSA Platform
- K230418 — Mighty Wire Guide Wire
- K233270 — AcuNav Crystal Ultrasound Catheter
- K213146 — Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen
- K220493 — Plaxpot Multi Plasma
- K222459 — Centrix FluoroSilver Silver Diamine Fluoride 38%
- K223541 — Cold/Hot Compression
- K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System
- K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System
- K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System
- K230490 — PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT
- K230826 — Modius Sleep
- K230854 — SwiftMR
- K231165 — Shina Syringe; Shina Safety Syringe
- K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
- K231310 — Electronic Blood Pressure Monitor
- K231494 — CoreLink Robotic Navigation Instruments
- K231545 — hearOAE
- K231761 — PodSKAN HF Diagnostic X-ray System
- K231908 — 45 Micron Polyisoprene Condom
- K231934 — GIA Stapler with Tri-Staple Technology
- K232045 — MeVis Liver Suite
- K232346 — Digital Expert Access with Remote Scanning
- K232348 — RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System
- K232393 — BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge
- K232618 — Aurora Surgiscope System
- K232667 — OR3O Dual Mobility Liners
- K233090 — DEKA AGAIN PRO family
- K233187 — Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
- K233207 — Polaris X Unidirectional Steerable Diagnostic Catheter
- K233220 — EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver (DRENCOR); EnCor MRI Breast Biopsy Driver (DRENCORMR); EnCor Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)
- K233241 — SOLACE Sacroiliac Fixation System
- K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
- K233318 — AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)
- K213473 — Antimicrobial Gelling Fiber Dressing with PHMB
- K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
- K230500 — Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)
- K230559 — Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
- K230662 — Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
- K231550 — Sontro® OTC Hearing Aids (AI)
Data sourced from openFDA. This site is unofficial and independent of the FDA.