FDA 510(k) clearances — page 97
clearances on record, most recent first.
Clearances — page 97
9,601–9,700 of 176,479- 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 +3 more
- 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®) +1 more
- 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) +4 more
- 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 (6 models)
- 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)
- K231579 — MOLLI 2
- K231595 — Electric Breast Pump
- K231685 — TE Air Diagnostic Ultrasound System
- K231737 — ANAX 5.5 Spinal System
- K232271 — SIMDA abutment
- K232500 — Lumify Diagnostic Ultrasound System
- K233091 — Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT) +1 more
- K233101 — Luja Coude (20108 Male CH18 - large packaging)
- K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) +3 more
- K233223 — OGmend® Implant Enhancement System
- K233234 — PressON Spinal Fixation System
- K233417 — AllTest Fentanyl Urine Test Cassette
- K221315 — UNIdental Symphony Implant System
- K221615 — Newclip Patient-matched instrumentation non sterile PSI
- K222997 — VVR Generator system
- K230284 — Penumbra LP Coil System
- K230511 — K3900 Ultrasound Imaging System
- K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II
- K230842 — SignalHF (IM008)
- K231069 — PERLA® TL Posterior Thoraco-lumbar Fixation System
- K231327 — POWERSEAL Sealer and Divider
- K231995 — AcuityUDR
- K232235 — Magstim®Horizon® 3.0 TMS Therapy System +4 more
- K232436 — Rapid SDH
- K233093 — Balanced Knee® System TriMax PS Plus Tibial Insert
- K233113 — ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)
- K233147 — PiXel8-RF
- K233210 — sam CS Long Duration Ultrasound Device
- K230472 — Sonopuls 190
- K230919 — Acumen IQ finger cuff
- K231509 — Aco Apache Ultrasound System
- K232051 — VISULAS green
- K232086 — spineEOS
- K232211 — REUNION Sacroiliac Joint Fusion System
- K232223 — PlaDuo System
- K232356 — Laser Cap, Model: Hat-01
- K232570 — Steerant Super Stiff Guidewire
- K232584 — Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter
- K232586 — Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System
- K232638 — FilteredFlo Warming Blankets
- K232683 — Knotilus+ PEEK Knotless Anchor
Data sourced from openFDA. This site is unofficial and independent of the FDA.