FDA 510(k) clearances — page 82
clearances on record, most recent first.
Clearances — page 82
8,101–8,200 of 176,479- K231142 — Temporis, Irix Plus
- K232246 — 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture +1 more
- 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 +3 more
- 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) +5 more
- 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 (7 models)
- 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 +6 more
- 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)
- K234073 — ICE Aspiration System
- K234092 — SafeOp 3: Neural Informatix Systeem
- K234119 — UniSpace® Stand-Alone C Cage
- K240162 — LIFEPAK® 35 AC Power Adapter (41335-000001)
- K240378 — FAQ 201, FAQ 202
- K240508 — Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
- K240534 — Bio-Medicus Life Support Catheter and Introducer
- K240753 — Miro3D Fibers Wound Matrix
- K240781 — SKOUT® system
- K230233 — Prospera Spectruum Negative Pressure Wound Therapy System
- K232325 — RAYSCAN a-Expert
- K232627 — HotDog Warming Mattress + Return Electrode
- K233850 — Difiney Anti Snoring Device
- K233924 — EMBOGUARD Balloon Guide Catheter
- K234098 — Mobility Scooter (C4+)
- K240046 — Ethylene Oxide Sterilization Supplier Change for MPO Hips
- K240085 — zLOCK Lumbar Facet Fixation System
- K240155 — Cochlear Osia System
- K240258 — Disposable Medical Face Mask (M643BE)
- K231646 — Carilex VT¿200-i NX
- K232238 — Goyo Mouthpiece S
- K233186 — uOmnispace.MR
- K233863 — TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-
- K240032 — Celerity Chemical Indicator for enspire 3000 CLCSPS
- K240039 — Enteral Feeding Sets
- K240057 — TraumaGuard Intra-abdominal Pressure Sensing System
- K240484 — MSFX Mikron Cervical Anterior Plate System
- K240519 — Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens
- K232133 — Co2 Laser System, Models: PureLase And VanLase
- K232202 — Aperio GT 450 DX
- K232208 — Sectra Digital Pathology Module (Version 3.3)
- K232256 — Alcantara Thoracolumbar Plate System
- K233886 — Ambu® aScope Duodeno 2, Ambu® aBox 2
- K233962 — ReBorn (1050nm)
- K240748 — nextaro® v, 20/20
- K223113 — Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
- K232904 — Access Ostase
- K232926 — Novalung ultimate kit (US)
- K233411 — Folysil Silicone Catheter
- K240205 — Ez Catch Auto; Ez Catch YR; Ez Catch TR
- K240773 — VisAble.IO
Data sourced from openFDA. This site is unofficial and independent of the FDA.