FDA 510(k) clearances — page 104
clearances on record, most recent first.
Clearances — page 104
10,301–10,400 of 176,479- K230976 — Arthrex Radiopaque FiberTape Cerclage sutures
- K231274 — Natural Cycles
- K231506 — Current Health System
- K231557 — ZENEX FreeMilling & CCM Cast Abutment
- K231599 — Stryker MP, Mandible, HMMF and MMF AXS Screws
- K231604 — Instrument Case
- K231680 — AccelFix Lumbar Expandable Cage System
- K231944 — CATAMARAN SI Joint Fusion System
- K232215 — Quantra Hemostasis Analyzer
- K232218 — Zenius Spinal System
- K232291 — Essenz HLM, Essenz ILBM
- K222946 — Oneday Mini Implant System
- K223590 — Access Folate Assay
- K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential
- K230610 — Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
- K230812 — Withings Scan Monitor 2.0
- K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack
- K232243 — EVO 700 series high speed handpiece
- DEN220052 — BrachyGel Vaginal Hydrogel Packing System
- K220938 — Nova HD+
- K223574 — IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)
- K230899 — qXR-PTX-PE
- K231205 — GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
- K231496 — TITAN 3-D Wedge System
- K231503 — CUPTIMIZE Advanced
- K231510 — Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)
- K231811 — Zavation Connector System
- K232190 — 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
- K222245 — ACR Screw System
- K223560 — Plato 17 Microcatheter
- K223813 — Aveta System 2.0
- K230486 — Cove Strip
- K231266 — Pediatric Nailing Platform Tibia
- K231731 — Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4
- K231763 — Stable-C Interbody System
- K231867 — Grappler Suture Anchor System
- K232185 — SM-IV
- K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312)
- DEN230019 — AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent) +1 more
- K220253 — Eco Abutment, Multiunit Abutment
- K222993 — Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs +1 more
- K223163 — Sleepiz One+
- K223526 — ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
- K223539 — Dreem 3S
- K223573 — Onera Sleep Test System (Onera STS)
- K223867 — IDS ACTH II
- K223883 — Daye Tampon
- K230579 — Smart Wedge algorithm
- K231026 — 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)
- K231053 — Unicare (K-UNICARE-USA)
- K231085 — 1.5T HD T/R Knee Array (10-F34127)
- K231096 — Automatic Continuous Effusion Shunt (ACES) System ACES System
- K231204 — Cochlear Osia® System +6 more
- K231257 — Pangea Utility Plating System, Pangea Platform
- K231262 — Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
- K231457 — SPARK Scan
- K231673 — P200TE (A10700)
- K231718 — Holmium Medical Laser
- K231777 — Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)
- K232144 — Sterile Products of the APTUS System
- K232150 — ZSFab Cervical Interbody System
- K232153 — Avéli
- K232157 — Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
- K232498 — UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
- K222772 — Oral/Enteral Syringe with ENFit connector
- K222773 — Feeding Tube
- K223167 — Spirair Nasal Septal Strap
- K223538 — Integrity Implant
- K223912 — InterCollagen® Guide
- K230415 — Cadwell Guardian
- K230588 — Aer-O-Scope Colonoscope System
- K230690 — Tandry Locking Plate System
- K230871 — EXTRON 5; EXTRON 7
- K231481 — Xpert Xpress CoV-2/Flu/RSV plus
- DEN220073 — Revi System
- K222148 — HemoScreen Hematology Analyzer
- K223479 — AQUAbase nX
- K223709 — Kyphoplasty Balloon Catheter
- K223922 — SOMNUM (V.1.1.2.)
- K230298 — Celsi Monitor
- K230314 — Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
- K230342 — Phototherapy System (OL-PDT950)
- K230577 — Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
- K230581 — TOPA12 Portable X-ray Unit
- K230832 — Powdered Free Sterile Natural Rubber Latex Surgical Gloves
- K231087 — Guided Surgery Kit
- K231389 — Harvest Dental HD Gum Strip
- K231491 — TA Stapler and Loading Unit with DST Series Technology
- K232116 — CoreLink Navigation Instruments
- K232126 — EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil
- K232141 — CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)
- K223874 — BAROguard
- K231094 — Annalise Enterprise CTB Triage-OH
- K231301 — Vscan Air
- K231455 — Implant-One System
- K231583 — Route 92 Medical Full Length 054 Access System
- K231750 — MA012 Aluminum wheelchair, MS019 steel wheelchair
- K231807 — primaLOK SP Interspinous Fusion System
- K231829 — Xenix Medical Sacroiliac Fixation System
- K231838 — RxSight® Insertion Device (63002)
Data sourced from openFDA. This site is unofficial and independent of the FDA.