FDA 510(k) clearances — page 298
clearances on record, most recent first.
Clearances — page 298
29,701–29,800 of 175,699- K161360 — U2 Total Knee System, PSA Tibial Insert
- K161587 — Memodyn Staple
- K162144 — iHealth Wireless Blood Pressure Monitor
- K162454 — PicoWay Laser System
- K162467 — Twin-Pass Torque
- K162624 — Pre-Formed Penile Silicone Block
- K162726 — Exactech® Equinoxe® Preserve Stem
- K162958 — MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge
- K163083 — VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)
- K163095 — Lyme B. burgdorferi (IgG) MarStripe Test
- K163440 — Stealth Staple System
- K160471 — Medline Non-Surgical Isolation Gown-
- K161158 — IDS-iSYS Intact PTHN
- K161949 — OsteoCool V-3 RF Ablation System
- K162055 — Acclarix LX8 Diagnostic Ultrasound System
- K162381 — HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs
- K163122 — NobelClinician, DTX Studio implant
- K163170 — Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352
- K163210 — Philips CombiDiagnost R90
- K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
- K162034 — OBS Electrosurgical Generator (Model: OBS-350A)
- K162098 — LED Phototherapy Device
- K162390 — ET Hybrid Abutment
- K162879 — Elite Expandable Interbody Fusion Device
- K163004 — Radifocus Glidewire Advantage Track
- K163058 — Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
- K161236 — Universa Firm Ureteral Stents and Stent Sets
- K161688 — Advanced Gynecological Applicator
- K161767 — Philips IntelliVue GuardianSoftware
- K161967 — FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm
- K162088 — Ecomed Disposable Angiographic Syringes
- K162285 — EBM iDO Viewer 1.2.1
- K162407 — L300 Go System
- K162427 — Vado Bi-Directional Steerable Sheath
- K162631 — VERIFY STEAM Integrating Indicator - Short
- K162842 — ASAHI PTCA Guide Wire ASAHI SUOH 03
- K162909 — CSX-30 Flat Panel Detector
- K163042 — chromID Strepto B agar
- K163211 — MAGNETOM Sempra with syngo MR E11S
- K163280 — RP Lite 760R
- K163312 — MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software
- K163324 — nordicBrainEx
- K163689 — 3M Clear Tray Aligner
- K161219 — Zmaxx T Series
- K161303 — dynaMX Compression Plate
- K162587 — ROCCIA® ACIF
- K162790 — V.A.C.ULTA Negative Pressure Wound Therapy System
- K162882 — KARL STORZ ICG Imaging System
- K163044 — ORTHOLOC® 3Di Ankle Fracture Plating System
- K163179 — Onli Intermittent Catheter
- K163281 — FastStroke
- K163368 — FITBONE TAA
- K163574 — Multi Modality Viewer
- K163660 — Pantera LEO
- K163693 — IntraClude Intra-Aortic Occlusion Device
- K163715 — Allura Xper R9
- K160976 — Altus Spine Interbody Fusion System
- K161273 — StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
- K162226 — Reliant Multistage Dilatation Balloon Catheter
- K162786 — PASS LP Spinal System
- K162988 — PreludeSYNC Radial Compression Device
- K163258 — CrossFT Knotless Suture Anchor with Disposable Driver
- K161466 — ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
- K161686 — F&P InfoSmart
- K162802 — Barrx Anorectal RFA Wand
- K162851 — eLyx-PRO
- K162924 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)
- K163006 — VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
- K163014 — AOS Small Bone Nailing System
- K163705 — EzRay Air W
- K170074 — nvc
- K160591 — D.O.R.C. Disposable Cryo Probe
- K161231 — Facilis Spinal System
- K161275 — EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip
- K161823 — Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
- K162606 — Elecsys TSH assay, cobas e 801 Immunoassay analyzer
- K162618 — CONCORD Plus Radiopaque Bone Cement
- K162962 — OrthAlign Plus System
- K163107 — Lifestyles Zero Lubricated Latex Male Condom
- K160589 — Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
- K160660 — Medline Waste Station
- K161090 — Cranial PSI
- K161178 — da Vinci Xi Surgical System
- K161255 — meso-relle (AAL34, AAL36, AM30G)
- K161414 — Anatomic Total Knee System
- K161418 — Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
- K161492 — Juno VPAP ST-A
- K161593 — GMI Frontier Dental Implant System
- K161650 — Polysmith Sleep System, Model NTI7593
- K162137 — Fever Scout Continuous Monitoring thermometer
- K162242 — Comfort Flo Humidification System
- K162397 — Titan 3 Low Speed Angle Attachments
- K162399 — Atellica CH Magnesium (Mg)
- K162430 — UniStrip1 Generic Blood Glucose Test Strips
- K162434 — NC Gallant PTCA Catheter
- K162472 — TrueBeam-TrueBeam STx-Edge
- K162764 — JAZZ FRAME SYSTEM
- K162932 — Ranfac Fat Aspiration Cannula
- K163069 — OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
- K163113 — Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
Data sourced from openFDA. This site is unofficial and independent of the FDA.