FDA 510(k) clearances — page 81
clearances on record, most recent first.
Clearances — page 81
8,001–8,100 of 176,479- K233695 — Medical HAL Lower Limb Type (HAL-ML)
- K233766 — Geneo X Elite
- K233864 — ASSURE Wearable ECG
- K234018 — CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System
- K234039 — AEON Endoscopic Powered Stapler (3 models)
- K240377 — LIFEPAK® ECG Cables
- K240954 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
- K232514 — MIM Dose Analysis
- K233800 — Vertos mild Device Kit (MDK-0002)
- K234033 — ViSiGi LUX (3 models)
- K240007 — Solar Compact (G4-1)
- K240392 — JAZZ Spinal System
- K240685 — Salvo® Spine System
- K232416 — AUTION EYE AI-4510 Urine Particle Analysis System
- K232454 — Viral Transport Media (VTM)
- K232491 — CT 5300
- K232648 — RODEO Telescopic Nail
- K232733 — Mbrace Cable
- K232735 — EMA 3D
- K232776 — Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer
- K232895 — B-Ultrasound Diagnostic System
- K232941 — Megaloop Button System
- K233157 — VaporMAX LDD; MOJo LDD; MegaJOULE LDD
- K233349 — Alinity m HSV 1 & 2 / VZV
- K233524 — Sleeved IC 2 Family +4 more
- K233687 — ECHELON Synergy V10.0
- K234021 — Masimo Stork
- K234088 — Emily's Care Nourish Test System (Model 1)
- K240126 — ProAM ALIF System
- K240185 — Cypris eXact Suture Placement Device
- K240297 — Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)
- K240625 — CORUS Navigation Access System
- K240800 — Access Intrinsic Factor Ab
- K240919 — Silk Voice (SMI-04)
- K240940 — Vial2Bag Advanced® 20mm Admixture Device
- K232445 — CSF-4 (CSF-4)
- K232464 — VereSee Optical Veres Needle System
- K232902 — EVA15 insufflator
- K232908 — Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)
- K233689 — Hope&Her Vaginal Dilators
- K233752 — Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps
- K233857 — Neodent Implant System Custom Abutments
- K240012 — Mobility Scooter (W3431)
- K240037 — Revi System
- K240261 — Siege Vascular Plug (3 models)
- K240636 — HemoScreen Hematology Analyzer
- K231722 — SmarTooth
- K232370 — Percutaneous Nephroscope System
- K232858 — ORskin Blue
- K233203 — Soft Tissue Augmentation Resorbable Matrix
- K233284 — Vial Adapter with Filter
- K233513 — Remex Spine Surgery Navigation System II
- K233516 — Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
- K234113 — MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
- K240279 — VIDAS TBI (GFAP, UCH-L1)
- K240829 — AuST Steerable Sheath
- K240882 — BruxZir® Esthetic
- K240900 — HOTWIRE RF Guidewire
- K240925 — DuraGraft Vascular Conduit Solution
- 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) +1 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.