FDA 510(k) clearances — page 281
clearances on record, most recent first.
Clearances — page 281
28,001–28,100 of 175,699- K163367 — GenetiSure Dx Postnatal Assay
- K163625 — NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System
- K170037 — Breathe Technologies Life2000 Ventilation System
- K170492 — xTAG CYP2D6 Kit v3
- K170574 — Diacap Pro Dialyzer
- K170624 — TalarLift STS
- K171433 — Silk'n Infinity
- K171657 — ShurFit 2C Lumbar Interbody Fusion System
- K172122 — SOZO
- K172140 — NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)
- K163121 — SmartUs EXT-1M/3M
- K170488 — Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr
- K171116 — 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S
- K171200 — Grandio blocs
- K171337 — LENSAR Laser System fs 3D (LLS-fs 3D)
- K171431 — HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm
- K171493 — MegaVac Mechanical Thrombectomy System
- K171565 — OEC Elite
- K172114 — Zimmer Natural Nail System
- K163167 — CKS Plus Knee System
- K170060 — M22 and ResurFx Systems
- K170134 — Reperen Surgical Mesh
- K170787 — Powered Wheelchair DYW30A(D09)
- K170827 — INTRACEPT Intraosseous Nerve Ablation System
- K171070 — WS80A Diagnostic Ultrasound System
- K171071 — StimSox(TM) System
- K171809 — Epic Biliary Endoscopic Stent System
- K172066 — DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
- K172091 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
- K172096 — Fraxis
- K162948 — Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials
- K163133 — ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA
- K163225 — AFIAS iFOB with AFIAS-50
- K163390 — iC-GPC Assay TM for use on the iC-SystemTM
- K163446 — AxoGen Nerve Cap
- K170272 — TruMatch CMF Titanium 3D Printed Implant System
- K170529 — Delight, Delight ortho, B&Lite S
- K170588 — DESS Dental Smart Solutions
- K170845 — MiniMAX
- K170888 — Renovis S141 Lumbar Interbody Fusion System
- K170939 — Supplemental Instrument Trays
- K171389 — EVOLUTION Revision CCK System
- K171444 — YUKON OCT Spinal System
- K171451 — Ahmed Glaucoma Valve Model FP8
- K171707 — GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A
- K171735 — PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set
- K171881 — JAZZ Passer Band
- K172084 — Delta III Lithotripter
- K172129 — HS40 Diagnostic Ultrasound System
- K170038 — FuzeFix Screw System
- K170738 — InMode Diolaze XL
- K170851 — Anterior Spine Truss System (STS) Interbody Fusion Device
- K171362 — Merit Syringe
- K171386 — dpl SpectraLite
- K171684 — Epix Electrosurgical Probe with Smoke Evacuation
- K171712 — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach
- K152300 — Glucommander
- K160850 — Nucleoss Tpure Implant System
- K163251 — Life Essence Universal Porcelain System
- K163393 — Hi-Dow Wireless TENS/EMS System (Model HD-5N)
- K170861 — Premier
- K171147 — REVEAL Bulk
- K171345 — Cellvizio 100 Series Systems with Confocal Miniprobes
- K171366 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit
- K171596 — ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
- K172081 — Maestro Microcatheter
- K161358 — Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds
- K162507 — Arzzt 3.5 / 4.5 Small & Large Fragments System
- K162744 — Everyway OTC EMS, Model EV-805
- K170919 — The TiBow Expandable Spacer System
- K170928 — CADence System
- K171164 — U-Lite EXP
- K171322 — eCareManager 4.1
- K171356 — Clarity Reveal
- K171390 — dpl II Panel
- K171456 — Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
- K172036 — Medrobotics Flex Robotic System
- K172039 — CATHTONG II PICC Catheter
- K162832 — 731 Series Ventilators
- K163704 — Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card
- K170651 — Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
- K170712 — Accutorr 7/VS-900 Vital Signs Monitor
- K171038 — Hearing Healthcare Pro
- K171172 — Skyn Original Polyisoprene Lubricated Male Condom - Flavored
- K171595 — M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
- K171717 — AUTOCON III 400
- K172004 — truSculpt
- K170285 — AED Sinuscope
- K170565 — LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
- K170885 — DD cubeX2 HS
- K170894 — Zirconia Dental Ceramics
- K171062 — BP5S Wireless Blood Pressure Monitor
- K171075 — Calix-C Cervical Interbody Spacer
- K171077 — HEXA100 (hexafocon A) Daily Wear Contact Lenses
- K171079 — Q-Switched Nd:YAG Laser System
- K171315 — Advanced RBC Application
- K171369 — M.U.S.T. MINI Posterior Cervical Screws System
- K171619 — 14Fr Colon Decompression Set, Macon Colon Decompression Set
- K171639 — Trojan Supra Lubricated Polyurethane Male Condom
- K171758 — M.U.S.T. Combined Set Screws
Data sourced from openFDA. This site is unofficial and independent of the FDA.