FDA 510(k) clearances — page 289
clearances on record, most recent first.
Clearances — page 289
28,801–28,900 of 176,542- K162917 — Allerhope Allergy Skin Tester
- K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
- K163339 — SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
- K163500 — IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)
- K170384 — Dentium NR Line CAD/CAM Abutments
- K170531 — Ureteral Dilators and Percutaneous Nephrostomy Dilators
- K170555 — U Deliver Bolink ENFit Enteral Feeding Sets
- K170979 — ARIX Ankle Fibula Hook Plate System
- K171028 — CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories
- K171156 — OMNI Anseris Hip Stem
- K171475 — DeRoyal Laprador Specimen Retrieval System
- K171793 — Sequential Circulator SC-2004FC-OC
- K171983 — Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory
- K171993 — Zimmon Needle Knife Papillotome
- K172165 — Q-Fix Suture Anchor
- K172204 — BD Intima II PLUS Closed IV Catheter System
- K172220 — Advanced Perfusion System 1
- K162768 — ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables
- K163568 — SHOFU RESIN GLAZE
- K170064 — GLUCOCARD W Blood Glucose Monitoring System
- K170910 — Medacta Anatomic Shoulder Prosthesis
- K170968 — PROPHECY INVISION Pre-operative Navigation System
- K171651 — EXCELSIUS GPS
- K171950 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)
- K172162 — ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems
- K172175 — CapSure® PS System
- K172426 — Clear Blue Digi LED Curing Light
- K163483 — PANA SPRAY Plus
- K163570 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
- K170222 — Rapid Tox Cup II
- K170872 — Aisys CS2
- K171118 — Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
- K171162 — Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield
- K172163 — Eclipse Treatment Planning System
- K172374 — ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
- K163398 — ATLANTIS suprastructures
- K170321 — 3M Comply Hydrogen Peroxide Chemical Indicator 1248
- K170780 — ARIX Foot System (2.3/2.8)
- K171332 — Artemis Neuro Evacuation Device
- K161225 — Paonan Armstrong Posterior Spinal Fixation System
- K162729 — Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
- K162977 — ADVIA 2120i, ADVIA 2120
- K163166 — EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
- 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. +2 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.