FDA 510(k) clearances — page 73
clearances on record, most recent first.
Clearances — page 73
7,201–7,300 of 175,620- K240986 — Cold Compression
- K232528 — Protective Cap
- K232889 — METICULY Patient-specific titanium maxillofacial mesh implant
- K232923 — Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)
- K233122 — High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
- K233231 — Dental Implants and Abutments
- K233403 — Flexset System
- K240118 — Picosecond Nd:YAG Laser System
- K240156 — LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)
- K240621 — Morpheus® Moldable; Agilon® Moldable
- DEN230052 — Eversense AP CGM System
- K232511 — Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
- K233699 — SubtleREFORMAT (1.x)
- K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
- K240062 — ARVIS® Shoulder
- K240102 — Blood Pressure Monitor (TMB-2287-B)
- K240248 — Volnewmer
- K240526 — POWEReam Xia/Serrato
- K240568 — DuraPro Oscillating System
- K240584 — XTRA Autotransfusion System (with XTRA Bowl sets)
- K240591 — restor3d Kinos Axiom Total Ankle System
- K220272 — cobas pulse blood glucose monitoring system
- K221688 — ASTar BC G- Kit and ASTar Instrument
- K232038 — BioStar Single Use Transbronchial Aspiration Needle
- K232261 — TME Temporary Myocardial Electrode
- K232298 — DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl
- K232302 — Pocket III
- K232317 — UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
- K232435 — Rhinolaryngoscope system
- K232799 — syngo.via RT Image Suite
- K233583 — FCT iSTREAM Phase 1
- K233673 — uMR Jupiter
- K233703 — Bone Anchor (NGS-BA-01)
- K233873 — XLO Brand of Locking Distal Humerus Plating System
- K240091 — NB Mini Implant System
- K240299 — Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)
- K240324 — EMPOWR Revision Symmetric Knee Cones
- K240406 — Sonio Detect
- K240566 — Reef L Interbody System; WaveForm L Interbody System
- K240872 — Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
- K240879 — EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
- K231142 — Temporis, Irix Plus
- K232246 — 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture
- K232331 — InVision Precision LVEF (LVEF)
- K232357 — Copan Universal Transport Medium (UTM-RT) System
- K232405 — ENDOFIX EXO
- K232796 — LUOFUCON® Collagen Particles (Collagen Wound Dressing)
- K232805 — Kronos Electrocautery Device
- K233308 — Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)
- K233810 — Portrait VSM
- K234065 — CDI OneView Monitoring System
- K240535 — Digital ClarusScope System; Digital NeuroPEN System
- K240846 — CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
- K240855 — Dental Cone-beam Computed Tomography
- K232181 — Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)
- K233172 — NextAR Spine Platform
- K233764 — SSS-NX (Serum Substitute Supplement-NX)
- K234025 — 22.2mm BIOLOX® delta Ceramic V40 Femoral Heads
- K234056 — canturio® se (Canturio Smart Extension)
- K240093 — IPL Home Use Hair Removal Device (SJ15)
- K240208 — DESS Dental Smart Solutions
- K240319 — DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
- K240623 — Omnia Medical TiBrid-SA System
- K240822 — Image Management V15
- K240839 — OpenRad Cloud
- K240850 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
- K222958 — mJOULE RF System and Accessories
- K231699 — QUANTUM® Patient Specific Instrumentation (PSI) System
- K233329 — Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
- K233537 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
- K233849 — BTL-499
- K233948 — Provisio SLT IVUS System
- K234107 — Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)
- K234147 — ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)
- K240058 — AEYE-DS
- K240518 — swiftPro System
- K240816 — MeDioStar
- K240902 — Dexcom G7 Continuous Glucose Monitoring System
- K223515 — MamaLift Plus
- K232319 — Black Pearl Nitrile Examination Glove
- K233311 — Acumed Wrist Plating System
- K233582 — Rapid
- K233966 — Anterior Spine Truss System-Stand Alone (ASTS-SA)
- K234041 — Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)
- K234068 — ART-Plan (v.2.2.0)
- K240115 — Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System
- K240182 — Access EPO
- K232149 — BowTie SI Joint Fusion System
- K230120 — KeYi Total Knee System
- K232105 — APTUS Foot System 2.8-3.5
- K232204 — ReyaGel (RG03 - MTP gel 3mL)
- K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC)
- K232259 — Patriot-SI Posterior Implant System
- K232377 — Healgen Rapid COVID-19 Antigen Test
- K232566 — NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System
- K232962 — Patient Monitor (iX10, iX12, iX15)
- K233046 — Electrical Neuromuscular Stimulator, Cure Trio
- K233106 — AccuCath Ace Intravascular Catheter
- K233373 — Flowflex® Plus COVID-19 Home Test
- K233737 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
Data sourced from openFDA. This site is unofficial and independent of the FDA.