FDA 510(k) clearances — page 82
clearances on record, most recent first.
Clearances — page 82
8,101–8,200 of 175,620- K233355 — Cypris eXact Suturing System
- K233520 — Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
- K233677 — Biograph VK10
- K233694 — Meridian Interbody System; WaveForm A Interbody System
- K233964 — GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)
- DEN220066 — BrainSee
- K222929 — ToxiSeal Vial Adapter with External Balloon
- K231088 — Copper Foam Dressing (Prescription and OTC)
- K231633 — Disposable Hemoclip (AF series)
- K231774 — CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)
- K232250 — SurgiCount+ System
- K232285 — U-Lite PRO
- K232995 — Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe
- K233616 — Clevaligner Software (V1.0.0)
- K233664 — IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,)
- K233712 — PRIMA Humeral System; PRIMA TT Glenoid
- K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400)
- K232604 — LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
- K232955 — Numen Coil Embolization System; NumenFR Detachment System
- K233364 — Axon Therapy
- K233902 — Centurion Vision System (Active Sentry) (8065753057)
- K233903 — Zeta Cranial Navigation System (ZNS131-US)
- K233944 — CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments
- K232312 — GORE® PROPATEN® Vascular Graft
- K232597 — LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
- K232710 — Dental Cone-beam Computed Tomography
- K233327 — 1788 4K Camera System with Advanced Imaging Modality
- K231324 — DASI Dimensions (V1.0)
- K232106 — Air Gap Fiber
- K232412 — LungQ v3.0.0
- K232894 — HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124)
- K233035 — Electronic Muscle Stimulator (Model MP01)
- K233444 — InkSpace Imaging Small Body Array
- K233615 — Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1
- K231068 — autoSCORE
- K231608 — Teleport XT Microcatheter
- K232721 — Lifetech Cardio Temporary Pacemaker
- K221766 — Solon
- K231163 — HS Fiber Sutures
- K231263 — Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT
- K231273 — ArcherQA (V1.0)
- K231917 — VEA Align
- K232519 — ENDOCOLLECT Specimen Retrieval Bag
- K233229 — NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether
- K233316 — DESS Dental Smart Solutions
- K233679 — IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG)
- K221110 — LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
- K223228 — Dayspring
- K230277 — Pulse Oximeter(Model OHT60,OXH78)
- K230507 — Zimed Distal Medial Tibial Plate and Screw System
- K230996 — Pursuant Health Kiosk (G1.D5)
- K231033 — CEPTRE® Knotted UHMWPE Suture PEEK Anchor
- K231058 — Hudson RCI® AddiPak® Unit Dose Vial
- K231072 — Anthogyr FlexiBase® titanium bases for Axiom® BL
- K232136 — syngo.CT Applications
- K232330 — Lancing System
- K232808 — Butterfly iQ3 Ultrasound System
- K233556 — LED Eye mask (EY-20R, A20, EY-20N)
- K233671 — Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance
- K223397 — HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens
- K231256 — Carecube Negative Pressure Isolation Chamber
- K231707 — ResQ Administration Set
- K231779 — REMI AI Discrete Detection Module
- K232589 — Horos MD
- K233395 — Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)
- K233550 — MOSAIC 3D (Surgical Laser)
- K223714 — UniFit Dental Implant System
- K230438 — URIS Smart Path Implant System & Prosthetic
- K230986 — Bladder Scanner
- K232688 — NQ TMS for MDD (NQv1-MU-01)
- K233362 — Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
- K233790 — ACL TOP 970 CL
- K233856 — Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal
- K230006 — Ankyras
- K230891 — SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant
- K230985 — Planmeca Viso
- K230997 — EvoWalk 1.0 System
- K231055 — x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)
- K233405 — Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim
- K231084 — TearCare MGX System
- K231914 — Nurochek-II System
- K232518 — EndoSound Vision System; EVS
- K232756 — Colibrí
- K233858 — TriSalus TriGuideTM Guiding Catheter
- K231130 — TumorSight Viz
- K232937 — BTL-899M
- K233300 — POWEReam 1/4 Drive
- K233515 — Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
- K233659 — Suture Wing
- DEN230020 — BioTraceIO Lite
- K223745 — Novae® Dual Mobility System, Hype® Hip System
- K230267 — NeuMoDx CT/NG Assay 2.0
- K230439 — WellCare Anoscope
- K231086 — CPM System
- K231794 — Elegant Advanced CompHort
- K231805 — qXR-LN
- K232293 — kallisio stentra oral stent
- K232300 — ElastiMed SACS
- K232338 — Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
- K232479 — ART-Plan
Data sourced from openFDA. This site is unofficial and independent of the FDA.