FDA 510(k) clearances — page 167
clearances on record, most recent first.
Clearances — page 167
16,601–16,700 of 176,479- K202049 — Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
- K210997 — PreferX Delivery System
- K211579 — CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)
- K211607 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
- K211769 — OneLIF Intervertebral Body Replacement System
- K202796 — SANSIN Tubing Sets for Hemodialysis
- K211736 — Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
- K212081 — 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228
- K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
- K202689 — Dentilube Spray
- K202786 — Dental Low-speed Handpieces and Accessories
- K203536 — Male Latex Condom
- K210133 — Current Health Monitoring System Gen 2 (G2)
- K210342 — BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
- K210470 — C-CURVE Interbody Fusion Device
- K210861 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K210940 — LuxaPrint Ortho Plus
- K211200 — WoundExpress
- K211583 — Infrared Thermometer, Model: HW-1
- K211637 — AROMA GRAND
- K211762 — Altor Safety 4-Ply Surgical Mask (Model:62232)
- K212421 — ADAS 3D
- K212476 — KARL STORZ Flexible HD Cysto-Urethroscope System
- K201445 — MultiCath, AcQRate Dx Fixed Curve Catheter
- K201612 — Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5
- K203722 — RayPilot System
- K210868 — Nitrile Examination Gloves Powder Free (Blue)
- K211074 — Univers Revers Modular Glenoid System, Standard Augment Baseplates
- K211201 — MagnetOs Easypack Putty
- K211778 — Nitrile Examination Gloves, Green/ Blue/ Black Color
- K211881 — AI Segmentation
- K212491 — Air Relax Pro Model AR-4.0
- K212494 — Lung Image Analysis
- K201258 — EASYMAX Tag Self-Monitoring Blood Glucose System
- K202204 — Tracheal Stent System
- K202395 — SP-1000, SP-2000
- K203014 — EndoLIF Delta-Cage and DoubleWedge-Cage
- K203625 — Numen Coil Embolization System; NumenFR Detachment System
- K210032 — Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)
- K210254 — MeMed BV
- K210901 — Elecsys Vitamin D total III
- K210951 — Leonardo Mini Blue
- K211174 — IPL Hair Removal
- K211367 — Evo sEEG System
- K211536 — Welspun Health Surgical Mask
- K211673 — Disposable Medical Nitrile Gloves
- K211823 — Bonine Acupressure Bands
- K211972 — Omeza Collagen Matrix
- K212139 — Admiral ACP System
- K201560 — Auto Lung Nodule Detection
- K203084 — Ablamap Software
- K203636 — PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS +1 more
- K210448 — Adhesive Electrode
- K210956 — Kubtec Mozart (XPERT42)
- K210957 — Kubec Xpert 80 Radiography System
- K211449 — Triton Sacroiliac Joint Fixation System
- K211704 — CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System
- K212083 — Tactoset Injectable Bone Substitute
- K212145 — DR 800 with DSA, DR 800
- K212383 — EndoNaut
- K210090 — Impulse AM Interbody Fusion System
- K210805 — Ceribell Instant EEG Headband
- K211041 — Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681
- K211322 — Paratrooper Plantar Plate Repair System
- K211630 — VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
- K211903 — Shoreline Threaded TruProfile® Plate
- K212054 — Senhance Surgical System
- K212070 — KMTI S141 Lumbar Interbody Fusion System
- K212103 — StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2
- K203554 — AnyOne External Implant System
- K211255 — Surgical Mask
- K211390 — Nitrile Blue Powder-free Examination Glove
- DEN200064 — Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System
- K202746 — Surgical mask
- K202752 — AXS Vecta 46 Intermediate Catheter
- K202781 — Neuspera Neurostimulation System (NNS)
- K202861 — Needle Stimulator
- K203251 — SOLOPASS System
- K203613 — ENFit Reusable Enteral Syringe
- K203696 — RBknee
- K210047 — Stiletto Extended Dwell Catheter
- K210122 — Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
- K210373 — Clear Aligners
- K210502 — Trevo NXT ProVue Retriever
- K210530 — WOLF Thrombectomy System, 6F
- K210610 — PrimeTaper EV Dental Implant
- K210676 — XSTAT 30 Pouch
- K211373 — SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software
- K211413 — BEE PLIF Cage
- K211524 — LOGIQ E10s, LOGIQ Fortis
- K211684 — PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
- K211995 — Sonendo Filling Material 5C
- K212004 — MyoSPECT, MyoSpect ES
- K212023 — Virage Navigation System
- K212038 — K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
- K212345 — AcQMap High Resolution Imaging and Mapping System
- K200230 — Aptiva Celiac Disease IgG Reagent
- K200748 — Visby Medical Sexual Health
- K202802 — TT Electric Breast Pump, TT Double Electric Breast Pump
- K202831 — The iMask Child's Face Mask
Data sourced from openFDA. This site is unofficial and independent of the FDA.