FDA 510(k) clearances — page 164
clearances on record, most recent first.
Clearances — page 164
16,301–16,400 of 175,699- K210349 — TKO Composite Bite Turbo Gel
- K210666 — Chest-CAD
- K210684 — Disposable Nitrile Medical Examination Glove
- K210719 — Change Healthcare Anatomical AI
- K211192 — Grivamax Family of Lasers, Models 272 and 148
- K211302 — Elecsys Syphilis
- K211859 — ACUSON Sequoia Diagnostic Ultrasound System
- K211906 — Vital Signs
- K201147 — Elos® Intramedullary Nailing System
- K210877 — Evolve System with the T3 Applicator
- K210963 — ENNOVATE Spinal System
- K211188 — xvision Spine system (XVS)
- K211291 — Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
- K211548 — POLARSTEM Calcar Reamer Guide
- K211910 — Z-6 Atrioseptostomy Catheter
- K211177 — Powder Free Vinyl Patient Examination Gloves
- K211239 — Vinyl Patient Examination Gloves
- K193397 — ADVIA Centaur® Digoxin assay
- K201473 — ExoAtlet-II
- K203108 — Ignite Stemless Anatomic Shoulder System
- K203435 — Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System
- K210011 — JS Dental Lab Mouth Guard
- K210103 — SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX
- K210186 — PacBond One
- K210544 — Medtronic Extended infusion set
- K210761 — Velguard Surgical Face Mask
- K211111 — SureMAX-SA Cervical Standalone System
- K211525 — SwiftNINJA Steerable Microcatheter
- K211592 — Avanti Orthopaedics Ulnar Shortening System
- K211792 — StitchKit
- K211946 — Soniquence Reusable Bipolar Cable
- K200096 — Crosstex VH2O2 Chemical Indicators
- K201100 — Bio-Medicus Life Support Catheter and Introducer
- K201328 — Dexcom G6 Continuous Glucose Monitoring (CGM) System
- K202638 — Pain Therapy Device
- K202846 — TERA HARZ
- K210431 — ReCross
- K210750 — Acumed Clavicle Hook Plating System
- K211042 — Disposable Procedural Ear-loop Face Mask
- K211514 — Longeviti PorousFit implant
- K211547 — Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
- K211933 — EleVation Breast Biopsy System
- K193047 — N Latex FLC kappa, N Latex FLC lambda
- K200983 — Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine
- K201733 — Provident II Hip Stems
- K201844 — Surgical Face Mask, Surgical Mask
- K202067 — EliA SmDP-S
- K202304 — NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
- K202390 — Aduro Light Beauty Mask
- K202918 — OsteoSync Ti Dental Mesh
- K202989 — Myopia Master
- K203023 — Pisces Spinal System
- K203115 — ARVIS Surgical Navigation System
- K203496 — Nexo-Gide Bilayer Collagen Membrane
- K203509 — SMART FINDER
- K203728 — Darwin
- K211866 — Bencox THR System
- K192739 — Electric Wheelchair [Models: JRWD6010/JRWD6012]
- K200210 — ADVIA Centaur® Total hCG assay
- K203562 — Finetest Lite Blood Glucose Monitoring System
- K211237 — UltraTemp Rez II
- K211938 — Physica LMC Knee System
- DEN200039 — InSpace Subacromial Tissue Spacer System
- K203556 — Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
- K210244 — Disposable Medical Face Mask
- K210386 — Magneto Nasal Mask
- K210492 — InMode RF Pro System
- K210717 — Bone Screws dia. 5,0 mm
- K210723 — Nitrile Patient Examination Glove
- K210776 — Nitrile Examination Gloves
- K211113 — Zavation Spinal System
- K211491 — RadiForce RX370
- K211495 — EOS PMP
- K211506 — PowerLook Density Assessment V4.0
- K210578 — Medical Nitrile Examination Gloves (Power free, Blue)
- K200575 — TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM
- K200915 — Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs
- K201262 — Microwave Therapeutic System
- K201675 — VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
- K202517 — Cytrellis Dermal Micro-Coring System
- K210012 — Tamarin Blue PTCA RX Dilatation Catheter
- K210602 — AortaSTAT Occlusion Device
- K210607 — PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
- K210713 — HM70 EVO Diagnostic Ultrasound System
- K210821 — Medical PVC Examination Gloves
- K211088 — Grosz Play Feel
- K211107 — BTL-899 FP
- K211493 — Monarch Platform
- K211542 — PRIMO S
- K211574 — Extreme X8
- K192971 — Nebulizer Kit
- K193490 — SensiTox C. difficile Toxin Test
- K201835 — PRE-SURE
- K202579 — TruAbutment DS, TruBase
- K202922 — END 200 Endoscopic Tubeset
- K203148 — Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)
- K203158 — BioWave BioWraps
- K203659 — iSR'obot Mona Lisa 1.0
- K210104 — SurroundScope System
- K210267 — Disposable Surgical Mask
Data sourced from openFDA. This site is unofficial and independent of the FDA.