FDA 510(k) clearances — page 63
clearances on record, most recent first.
Clearances — page 63
6,201–6,300 of 176,479- K241353 — PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set
- K241835 — AirSculpt Body Contouring System (AIRS-1-SYS)
- K241899 — Pelvic Floor Stimulator (Intrelief PFE)
- K242187 — BioBrace®
- K242308 — Power wheelchair
- K242444 — HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
- K242638 — LED Light Therapy Machine (G1, G3, G4, G6)
- K242796 — CryoGlow (FW3XXXX)
- K243221 — RadiForce RX570; RadiForce RX570-AR
- K243354 — Remunity System
- K243355 — Ceragem Automatic Thermal Massager (CGM-MB-1902)
- K243362 — SmoothSkin Pure Switch (SSC1)
- K243408 — TACTIX Vector Syndesmosis System
- K243409 — KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
- K231655 — 4CIS® Chiron Spinal Fixation System
- K231859 — PrimmaArt
- K240650 — LungProtect
- K240818 — R2P Radifocus Glidewire Advantage
- K240897 — Cellinew
- K241390 — NeuroMatch
- K241995 — HyperFlex Bunion Correction System
- K242049 — SureCath Set
- K242258 — MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)
- K242318 — da Vinci SP Surgical System (SP1098)
- K242494 — OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct
- K242559 — Digital Temp
- K242631 — REGENETEN Bioinductive Implant
- K242657 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL
- K242810 — RadUnity (Version 1.0.0)
- K242961 — Intraluminal Applicator Set
- K243050 — TriMed Posterior Malleolus Fixation System
- K243118 — Arm Blood Pressure Monitor (model: BPM-A7VL)
- K243191 — Atlas Spine Lateral Expandable Interbody System
- K243193 — Cross Wise Multi-Use RF Adapter Cable
- K232588 — Aluna 2
- K232982 — EMS Sculpt Machine
- K240575 — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
- K241588 — Electric Wheelchair (KR8803)
- K241692 — MIS LYNX Conical Connection Implant System
- K241831 — Transpara (2.1.0)
- K241851 — Versus Catheter (VS110-8B)
- K242245 — Customized Abutment
- K242253 — JARVIS Glenoid Reverse Shoulder Prosthesis
- K242538 — 3M Attest Super Rapid Readout Biological Indicator 1493 +4 more
- K242971 — AccurSound Electronic Stethoscope (AS101)
- K243162 — World Liner
- K243345 — Aptima BV Assay; Aptima CV/TV Assay
- K221326 — Nova Allegro HbA1c Assay, Nova Allegro Analyzer
- K233567 — OsteoCoil Nitinol Compression System (Multiple Component PNs)
- K240632 — Neuvotion NeuStim NN-01
- K241169 — Entarik NI Feeding Tube System
- K241529 — Powered Wheelchair (NXN20-209)
- K241953 — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
- K242002 — FemVue MINI Saline-Air Device
- K242094 — Dreem 3S
- K242203 — BriefCase-Quantification
- K242259 — Cala kIQ
- K242543 — Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)
- K242722 — Manual Wheelchair (MASY23)
- K242884 — Additively Manufactured Denture Resin
- K242913 — Jasmate® Toothpaste
- K242927 — Suction Irrigation Tubing Set
- K242968 — Giftlife® Single-Step Medium Plus
- K243334 — Nooro Body & Foot Stimulator (SM9141, SM9142)
- K232520 — Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH
- K240569 — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
- K241157 — Secret MAX Multi-platform RF System
- K241210 — Luja Coude
- K241319 — SKR 3000
- K241495 — Jazz Classic
- K242414 — TiLink-P Joint Fusion System
- K242553 — MIRARI® Cold Plasma System ( GV-M2-01)
- K242596 — Versalock Mini and Micro Plating System
- K242799 — PliaFX Flo
- K242871 — ATTUNE Revision Hinge Knee
- K242874 — Gating Reflector Block
- K242998 — GMReis Ankle Plating System
- K243405 — Xpert vanA
- K232965 — Leg Massager (Models:RP-ALM070H, RP-ALM071H)
- K240716 — AETOS Shoulder System Stemless Humeral Prosthesis
- K240746 — Neurovascular Access System Family
- K240856 — Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds
- K241603 — Powered Wheelchair (NXN20-208, NXN20-211)
- K241843 — TD-7301 Spirometer (TD-7301)
- K242291 — SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle
- K242359 — Strain AI (SAI001)
- K242363 — HIGHERDOSE Red Light Hat (HG-120K)
- K242517 — ProAM ACDF System
- K242520 — Element Vascular Access System
- K242521 — Estar-ZE
- K243064 — ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
- K243164 — INDIBA COMPACT devices
- K221349 — XPER Technology PREMIUM Pro Blood Glucose Monitoring System
- K221813 — Nova Allegro UACR Assay, Nova Allegro Analyzer
- K242028 — Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)
- K242102 — CerroZone Mini
- K242293 — Medical Thulium Fiber Laser Systems (UroFiber 60Q)
- K242496 — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
- K242516 — EUROPA Posterior Cervical Fusion System
- K242523 — ACUSON Sequoia Diagnostic Ultrasound System +3 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.