FDA 510(k) clearances — page 143
clearances on record, most recent first.
Clearances — page 143
14,201–14,300 of 176,479- K220420 — Saffron Fixation System
- K220528 — Surgical Isolation Cover Gown
- K220796 — IntellaMap Orion High Resolution Mapping Catheter
- K220894 — SmileGuard
- K221065 — MediLab
- K221087 — Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
- K221362 — Omni Foot and Ankle Plating System
- K221376 — Nalu Neurostimulation System
- K221393 — Swoop Portable MR Imaging System
- K221658 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- K211000 — ACUTRON
- K211909 — Cysto-Gastro-Sets
- K211981 — KHEIRON® Spinal Fixation System
- K212663 — HELIOS IV 785
- K213258 — Nasogastric Feeding Tubes - ENFit Port - PVC
- K213587 — MyCRO Band
- K220259 — ALLY Adaptive Cataract Treatment System
- K220717 — RedPoint Medical's Better Bunion System
- K220729 — The Luminance RED Acne Device
- K220782 — IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody System
- K220988 — EksoNR
- K221071 — Niti-S Biliary Slim M Stent
- K221077 — Auryon Atherectomy System
- K221339 — Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
- K221368 — Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
- K212933 — INHANCETM Hybrid Anatomic Glenoid Implant
- K213173 — TrabEx Pro
- K213185 — ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits
- K213717 — AIR Recon DL
- K213862 — HD60 Series Ultrasound Diagnostic System
- K213882 — EarliPoint System
- K221371 — Promisemed Heel Blood Lancet
- K221389 — FairFix AM Adjustable Button FairFix PSP Adjustable Button
- K203579 — Infinity Gateway Suite
- K210804 — Adhese Universal DC, Cention Primer
- K213087 — Natural Rubber Latex Ultrasound Transducer Probe Covers
- K213117 — FX V135 Shoulder Prosthesis
- K220455 — Lap-Band System Calibration Tube
- K220693 — Zoupure Nitrile Powder Free Examination glove
- K221160 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
- K221335 — D²RS and D²RS 9090
- K221438 — WHILL Model F
- K211207 — Diacare 7000
- K212450 — Keos Anterior Cervical Interbody Fusion Device System
- K213222 — Disposable Polypectomy Snare
- K213223 — Multi-Band Ligator
- K213448 — Powder Free Nitrile Gloves
- K220358 — Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
- K220612 — PrimeLOC Attachment System
- K220947 — Arthrex Knotless AC Repair Devices
- K221222 — Surgical Face Mask (HNFM0304)
- K221231 — Drug Relief v1
- K221366 — Smart Correction System Rings and Compatible HA-Coated Half Pins
- K213846 — Q2 Blood Administration Sets
- K210084 — SILKRO
- K210371 — Portable Oxygen Concentrator, model: P2-E6
- K210741 — KLS Martin Neuro Rongeurs
- K211046 — eCareManager 4.5
- K211567 — BiMobile Instruments (for BiMobile Dual Mobility System)
- K213332 — Multifrax Laser System
- K213924 — Gastric Alimetry System
- K213931 — VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
- K213971 — Atrial Fibrillation History Feature
- K213977 — TrueBeam, TrueBeam STx, Edge, VitalBeam
- K213988 — SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
- K214063 — Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
- K214089 — FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
- K220205 — 3D Anatomic Models
- K220321 — Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris
- K220633 — MICROLET NEXT lancing device, MICROLET Lancet
- K220652 — Knee 3
- K220665 — Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile
- K220672 — Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim
- K220761 — CIRCUL8 Connect DVT Prevention Device
- K221061 — 21HQ613D
- K221314 — BriefCase
- K200754 — Hemosure Accu-Reader A100
- K210758 — Q Patch
- K212288 — Minjie Catheter System
- K213239 — Endoscopic Injection Needle
- K213261 — EpilME
- K213588 — Q2 IV Administration Sets
- K214049 — Leaseir MHR Xcell
- K220008 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
- K220164 — Rayvolve
- K220541 — PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves
- K220547 — PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
- K220581 — Zavation eZspand Interbody System
- K220632 — Boss Crossing Support Catheter
- K220751 — Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
- K220861 — M6-C Artificial Cervical Disc Instruments AS
- K220927 — IPL Hair Removal
- K220930 — Restoris Multi-Compartmental Knee System
- K203233 — 4CIS Chiron Spinal Fixation System
- K210107 — Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
- K212445 — freeflex+ Transfer Adapter
- K213201 — DeltaFil, DeltaFil Conditioner
- K213753 — Purgo
- K213838 — AneuGuide
- K220058 — BeneVision Central Monitoring System
Data sourced from openFDA. This site is unofficial and independent of the FDA.