FDA 510(k) clearances — page 62
clearances on record, most recent first.
Clearances — page 62
6,101–6,200 of 175,620- K240203 — URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)
- K241155 — Cold Sore Device (QPZ-03)
- K241356 — Fine Osteotomy
- K241605 — Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology
- K241721 — Electric wheelchair (N3901)
- K241723 — Electric wheelchair (W3902)
- K242390 — Novum IQ Syringe Pump (40800BAXUS)
- K221275 — Qraycam PRO
- K231095 — Tamper Evident Cap
- K231502 — Mini Screws
- K233977 — Velacur
- K240142 — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
- K240158 — Modular Medical MODD1 Insulin Delivery System
- K240646 — DreamClear
- K241071 — NextDent Jet Denture Base; NextDent Jet Denture Teeth
- K242305 — BE Plus PRO, Neurotravel LIGHT
- K242306 — SignalNED System (Model RE)
- K233805 — K5
- K240487 — EVOS Patella Plates
- K241295 — SOMATOM On.site
- K241611 — ShapeIT (SI014135)
- K242069 — Eminent Spine Scoliosis Deformity Pedicle Screw System
- K242251 — Litho 60; Litho 100; Litho 150
- K242319 — Indigo® Aspiration System Aspiration Catheter 6X
- K241592 — Arthrex VAL and VAL KreuLock Compression Screw System
- K231969 — BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
- K232441 — Unipro (K-UNIPRO-US)
- K233107 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
- K233872 — Daylight
- K233932 — Alinity i Toxo IgM
- K234027 — embecta Insulin Delivery System
- K240003 — Velmeni for Dentists (V4D)
- K240180 — Orthopeasia Spinal Fixation System
- K240464 — WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
- K241051 — Vave Wireless Ultrasound System
- K241148 — Salto Talaris Ankle PSI System
- K241256 — JetBoots PRO Plus
- K241318 — Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
- K241326 — Cadence Ankle PSI System
- K241386 — Heyman Packing Applicator Set (GM11004580)
- K241393 — ODI-Tech
- K241518 — Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)
- K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
- K241585 — uMI Panorama
- K241602 — Kingcera Dental Zirconia Blank
- K241662 — Ultrasound Transducer Cover
- K241823 — ToxiSeal Vial Adaptor
- K241847 — Imbio PHA (4.0.0)
- K241957 — Talee, Talee PostOp
- K242249 — Conformity Stem Extension Line
- K242275 — syngo.via MI Workflows; Scenium; syngo MBF
- K242300 — MI View&GO
- K220908 — Ensol EnTM Specimen Collection and Transport System
- K233826 — Kosmos
- K240105 — Navigator (FMNVG15); Navigator XL (FMNVX06)
- K241227 — RHYTHMIA HDx Mapping System
- K241400 — SkinPen Precision Elite System
- K241881 — IPL Hair Removal Device (JM-843, JM-865, JM-638)
- K242243 — Target Detachable Coils
- K242280 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips
- K242296 — VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK)
- K242346 — Grass® MR Conditional/CT Cup Electrodes
- DEN230067 — Chronos®
- K232991 — BT-1000
- K233816 — REDEMPTION Charcot Plating System
- K233827 — OxiWear
- K240078 — Fogarty Thru-Lumen Embolectomy Catheter
- K240545 — GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)
- K241457 — Vista BC Putty
- K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack
- K241557 — Cercon® yo ML
- K241913 — da Vinci Handheld Camera
- K241932 — OSSIOfiber® Compression Staple
- K241943 — Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask
- K242316 — Safety Lancet
- K233846 — Vitrification Solution Set and Warming Solution Set
- K234151 — Isolator Synergy EnCapture Ablation System (EMH)
- K240270 — Electric wheelchair (S7018)
- K241228 — TENSWave
- K241241 — Z1 Cemented Hip System
- K241354 — Sealer Solvent
- K241517 — Q Guidance System; Mako Spine System;
- K241523 — injeTAK Adjustable Tip Needle (DIS199; DIS201)
- K241684 — Overjet Charting Assist
- K241787 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System
- K242212 — Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)
- K242537 — BracePaste Fluoride Sealant
- K240286 — PRIMED Surgical Masks and PRIMED Procedure Masks
- K240982 — DESS Dental Smart Solutions
- K241538 — TriClip Steerable Guide Catheter
- K241607 — MyoStrain (6.0)
- K241777 — SmartAdjust Technology
- K241850 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- K241858 — BARS Set (100.60)
- K242044 — FiAPC plus probes
- K231100 — Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw
- K233358 — SCoV-2 Ag Detect Rapid Test
- K233801 — Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
- K233829 — Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA)
- K240318 — SITTER 3.5mm Versatile System
Data sourced from openFDA. This site is unofficial and independent of the FDA.