FDA 510(k) clearances — page 303
clearances on record, most recent first.
Clearances — page 303
30,201–30,300 of 175,699- K163043 — Zeramex P6 Dental Implant System
- K163092 — TubeClear Control Box and Clearing Stem
- K163102 — ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm
- K163138 — Clarius Ultrasound System
- K163139 — PleuraFlow System with FlowGlide
- K160642 — Medline ENFit Syringe
- K160801 — Well Lead Extraction Bag
- K161013 — InnoSEAL Hemostatic Pad
- K161776 — Lenstec LC Injection system
- K162414 — UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
- K162466 — LuminScan (TM) Imaging System
- K163066 — TxRx Knee 15 Flare MR Coil 3.0T
- K160530 — Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
- K160720 — Carriere Motion Clear Class II
- K161932 — Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
- K161962 — VAMP Venous/Arterial Blood Management Protection System
- K162211 — AccuFit Lateral Plate System
- K162451 — Solana HSV 1+2/VZV Assay
- K163207 — Filtek One Bulk Fill Restorative
- K161819 — NNR06 Multi-Purpose Solution
- K162183 — Vantage Galan 3T, MRT-3020, V4.0
- K160545 — GAP ENDO-EXO MEDULLARY SYSTEM
- K160705 — Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
- K160872 — PolyPlex Wound Dressing
- K160940 — Masimo Disposable Transflectance Forehead Sensor
- K161264 — TRIGEN Low Profile Bone Screws
- K161696 — aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
- K161863 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
- K161957 — W&H Implantmed SI-1015 incl. Accessories
- K162103 — Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)
- K162148 — Allura Xper R9
- K162396 — SILK Surgical Suture
- K162444 — Xpert MRSA NxG
- K162462 — AMICUS Separator System, AMICUS Separator System; Refurbished
- K163007 — Biomet Microfixation SternaLock 360 Sternal Closure System
- K152906 — Disposable High Pressure Injector Syringe
- K153021 — Fingertip Pulse Oximeter A310
- K153773 — Disposal Lens Cleaning Sheath
- K160594 — MRWire Guide Wire
- K160761 — DW-1C
- K160855 — U&U Enteral Syringe
- K160884 — CXI Support Catheter
- K161277 — ConvertX Nephroureteral Stent System
- K161408 — Compass Cast and MAP
- K161435 — Temporary Snap Abutment
- K161708 — Arm automatic blood pressure monitor
- K161747 — LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5
- K161763 — Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
- K161778 — ToeTac 10° Hammertoe Fixation System
- K161873 — Pacel Flow Directed Pacing Catheter
- K161993 — Leva® Anterior Interbody System
- K162043 — NobelProcera HT ML FCZ Bridge
- K162092 — Evolv Model BP7000 Upper Arm Blood Pressure Monitor
- K162102 — MAGNETOM Avantofit, MAGNETOM Skyrafit
- K162191 — NAVILAS Laser System
- K162218 — Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102
- K162225 — WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System
- K162300 — Reform® POCT System
- K162316 — Pirouette 014
- K162355 — Raycast MammoRx Carbon Fibre Breast Board
- K162743 — ViewPoint 6
- K162970 — FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator
- K162971 — Multix Fusion Max
- K160132 — Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC
- K160508 — Electronic Pulse Stimulator
- K160656 — CorSens
- K160762 — Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
- K160786 — RODO Abutment System
- K161457 — XEN Glaucoma Treatment System
- K161700 — SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
- K161782 — Arthrex Univers Revers Shoulder Prosthesis System
- K161891 — HC Primer
- K161944 — Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
- K162024 — AltiVate Anatomic Shoulder System
- K162050 — ZELTIQ CoolSculpting System
- K162175 — Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
- K162220 — DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage
- K163185 — OptiLux LED Illuminator
- K152232 — Quest Diagnostics HairCheck-DT (Cocaine)
- K153394 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator
- K160558 — RAPIDO HOLLOW-FIBRE DIALYZERS
- K160595 — PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
- K160933 — Discovery NM 750b Bopsy
- K161472 — Walk-O2-Bout
- K161673 — LacriPro Punctum Plug
- K161795 — MAGNETOM ESSENZA
- K162078 — EVOS Small Fragment Plating System
- K162160 — Preference Elite Pedicle Screw System
- K162198 — GFS Ultimate
- K162230 — Fully Automatic Electronic Blood Pressure Monitor
- K162363 — V30 system, V-Form Handpiece BC Medium applicator
- K162403 — HyperBand
- K162577 — Dosimetry Check Version 5 Release 1
- K162994 — Capillus302, Capillus312, Capillus352
- K160045 — Heyman Packing Applicator Set
- K160564 — TroClose1200
- K160682 — CONTOUR NEXT ONE Blood Glucose Monitoring System
- K160923 — REDAPT Anteverted Cemented Liner
- K160959 — Xsert Lumbar Expandable Interbody System
- K161074 — Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
Data sourced from openFDA. This site is unofficial and independent of the FDA.