FDA 510(k) clearances — page 86
clearances on record, most recent first.
Clearances — page 86
8,501–8,600 of 176,479- K233381 — DRX-Evolution Plus System
- K240132 — EmoLED (v. 2-USA)
- K240416 — Tranquil-C Interbody System
- K240424 — Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix
- K240497 — Smartxide Tetra Pro
- K231758 — NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
- K231789 — Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)
- K231864 — Fiber Optic Brushless Electronic Micromotor, model: iM100
- K232140 — OTS Hip
- K233724 — 28mm/38D MDM X3 Insert for MDM Liner
- K233912 — ARIX Cannulated Screw System
- K233922 — SP NEWTRON CAN-A +4 more
- K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
- K234015 — Caphosol® Artifical Saliva (32 doses sachet box)
- K233083 — Osteon Precision Milled Suprastructure
- K230195 — Neo ADVISE software
- K231056 — Esperance Distal Access Catheter
- K231734 — STERiJECT Low Dead Space, STERiJECT The Invisible Needle
- K231760 — HP-OCT (HP-OCT)
- K231813 — Ultrasonic Gastrovideoscope
- K231904 — Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
- K232826 — Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)
- K233038 — Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
- K233177 — Nest VT Vitrification Device
- K233198 — OSSIOfiber® Threaded Trimmable Fixation Nails
- K233359 — DOMINION Expandable Corpectomy System
- K233421 — RESCAN 700
- K233438 — SleepStageML
- K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro)
- K233705 — CellFX Percutaneous Electrode System (SYS3000)
- K233758 — Trivicta Hip Stem
- K233899 — Knee+
- K233943 — Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
- K234046 — WallFlex Colonic Stent System with Anchor Lock Delivery System +3 more
- K240264 — Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)
- K240384 — SENDERO Microcatheter
- K240396 — Elite iQ PRO (M122K1)
- K232207 — D·Kutting PTA Scoring Balloon Dilatation Catheter
- K232781 — Safety Sliding Blood Collection Set
- K233692 — Voluson Signature 20, Voluson Signature 18
- K240371 — 0909FCC, 0909FCC-HS
- K240407 — ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor
- K240458 — Synthetic Bone Putty
- K231403 — evoDrill Cranial Perforator
- K231497 — Choledochoscope System
- K231677 — EdgeFlow UH10
- K231786 — Gynethotics Pessary
- K232004 — Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector
- K232270 — DVT Motion Pneumatic Compression Device
- K232424 — CurrentBody Skin RF
- K232703 — Disposable Bipolar Forceps
- K233021 — BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device
- K233075 — BioGend Interbody Fusion System 001 Cage
- K233572 — Autofuse
- K233794 — Insulin Syringe
- K233880 — Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)
- K240273 — Access Free T4
- K240351 — FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)
- K240352 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes
- K240619 — e-SDF
- K231210 — DGA Abutment
- K231260 — HTx Disposable Hysteroscope System
- K233526 — Medline Open-back Level 3 Protective Gown
- K233859 — BASIS FLOW II
- K234070 — Stelo Glucose Biosensor System
- K240090 — Argo Knotless GENESYS Anchor
- K240404 — NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)
- K240459 — Cerament Bone Void Filler
- K240597 — TERA HARZ CLEAR
- K230047 — Medical Diode Laser Systems
- K231288 — Vyvo
- K233738 — Overjet Caries Assist-Pediatric
- K233877 — XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)
- K240453 — ReBOSSIS
- K231365 — Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves
- K231648 — Muscle Stimulator
- K231690 — iCAS-LV
- K231778 — Nihon Kohden NKV-550 Series Ventilator System
- K231915 — Zfx Abutments
- K232040 — Gynatrof
- K232316 — DEKA Infusion System, DEKA Administration Set
- K232328 — Insignis Syringe Infusion System
- K232385 — OxiplexTS200
- K232791 — Access Intact PTH
- K232828 — IMAGEnet6 Ophthalmic Data System
- K233030 — BoneMRI
- K233095 — S21 OTC Transcutaneous Electrical Nerve Stimulator
- K233410 — LIAISON PLEX Respiratory Flex Assay
- K233862 — NUNA LUX (NUNL528)
- K240023 — Probe Covers (YF-001, YF-002)
- K240083 — GORE® PROPATEN® Vascular Graft
- K240277 — MiroDry Wound Matrix
- K230837 — PlazMagik
- K231683 — inHEART Models
- K232765 — MAGNETOM Cima.X Fit
- K232842 — Balloon Inflation System
- K232971 — APRO 55 Catheter and Alembic Aspiration Tubing
- K233360 — Curiteva Thoracolumbar Plate System
- K240051 — Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
- K240244 — NPseal (Small, Medium, Large)
Data sourced from openFDA. This site is unofficial and independent of the FDA.