FDA 510(k) clearances — page 54
clearances on record, most recent first.
Clearances — page 54
5,301–5,400 of 175,620- K243444 — BIOCERAM AZUL® HEAD
- K243447 — Rapid Surgical Plan (RSP-SW-001)
- K243463 — BIOFIRE FILMARRAY Tropical Fever Panel
- K243526 — MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
- K240671 — XBeam (v2)
- K241197 — DeepRhythmAI
- K242184 — Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
- K242185 — Rextar Pro
- K242301 — Socrates 38 Catheter
- K242348 — Locking Screw,CoCrMo
- K242395 — Nanox.ARC
- K242643 — CapsoCam Plus (SV-3) Capsule Endoscopy System
- K242685 — Atellica® CH Creatinine_3 (Crea3)
- K242686 — Neodent Implant System
- K242831 — Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System
- K243180 — SSPC NXT Delivery Catheter
- K243265 — Ion 3D
- K243417 — RelieVRx
- K243475 — Chemical Indicator for enspire CLCSPS (LCC015)
- K241486 — Sofsilk Coated Braided Silk Suture
- K242188 — ClearRead CT CAC
- K242861 — TrueLok Elevate
- K243454 — Verruca-Freeze H
- K243467 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
- K243470 — Fix2Lock (PEEK Self Punching)
- K223120 — Ventoux VC2; Ventoux VC3
- K240475 — Hintermann Series H2 Total Ankle System
- K241871 — Philips IntelliSite Pathology Solution
- K242619 — GroWell BT Hair Growth System (GW10042)
- K243020 — MIDASVu
- K243232 — GripMate
- K243418 — Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing
- K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
- K241090 — Evie Med Ring
- K241628 — YO Home Sperm Test
- K242225 — Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
- K243375 — Ruthless Spine RJB
- K233273 — C&B Ceramic; C&B Permanent; C&B Interim
- K240645 — Sonix Health
- K240994 — Nexpowder
- K241115 — SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter
- 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; 3M Attest Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.