FDA 510(k) clearances — page 125
clearances on record, most recent first.
Clearances — page 125
12,401–12,500 of 176,479- K221344 — nView s1 with nav option
- K221660 — RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
- K222760 — StageOne Select Hip Cement Spacer Molds
- K223286 — BD AutoShield Duo Pen Needle
- K223654 — Medussa-PL Cage
- K220974 — R:GEN
- K221669 — IOB Warming Blankets
- K221990 — Access Total ßhCG (5th IS)
- K222978 — Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
- K223094 — EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade +1 more
- DEN220017 — BioXmark
- K210017 — ACTOnco, ACTOnco IVD
- K211485 — STA- NeoPTimal
- K212239 — XENOVIEW 3.0T Chest Coil
- K214002 — CRYOcheck Chromogenic Factor IX
- K214036 — AVIEW
- K221048 — Episealer Patellofemoral System
- K221193 — OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm
- K221708 — CIMILRE Free-T2 Plus
- K221765 — ONLINE DAT Benzodiazepines II
- K222164 — Visant Medical Canalicular Plug
- K222726 — Smartpump 3.0 Double Electric Breast Pump
- K222748 — ShiNeo Silicone Implant
- K222924 — Leg Massager RF-ALM070
- K223071 — Xenoview VDP
- K223289 — Access Vitamin B12
- K223442 — MR 5300 and MR 7700 R11 MR Systems
- K223565 — LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
- K211058 — Lp(a) Ultra
- K221377 — SteriKing LT-Blueline Pouches with Tyvek
- K221396 — Arthrex FiberTak Suture Anchor
- K221428 — PerioStom Dental Dressing
- K222216 — TruWave Disposable Pressure Transducer
- K222262 — Sunrise
- K222774 — iFuse Bedrock Granite® Implant System
- K222806 — Kodiak C Spinal Implant System
- K222894 — Invisalign System, Pre-Formed Attachment System
- K222949 — Air Compression Leg Massager (Model: LY-670D)
- K223105 — Tesera-K SC System
- K223142 — Coltolux Comfort LED Curing Light
- K223273 — ASTRA Spine System
- K223311 — Philips CT 3500
- K223508 — Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
- K223547 — Biograph Vision Quadra PET/CT System
- K223649 — VERTICALE® Navigation Instruments
- K202965 — CURA-Temp
- K213235 — PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
- K213564 — BiWaze Clear System
- K213875 — DRI TM Tricyclics Serum Tox Assay
- K213893 — Comfort Gown, Safewear Gown
- K220012 — BresoDX1
- K220286 — ELECTROCYN soma
- K221054 — CORE-INJECTOR
- K221221 — Advanced Intramedullary Nail System
- K221698 — Eargo 5 , Eargo 6
- K221720 — Extra Silver Gelling Fiber Dressing
- K221826 — BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
- K221902 — LimFlow Vector
- K221911 — VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP
- K222234 — GlucoSure ADVANCE Link Blood Glucose Monitoring System
- K222351 — inspired VHB20 Heated Humidifier
- K222538 — NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter
- K222586 — Mural Clinical Viewer
- K222637 — TriMed Wrist Fixation System 3
- K222864 — 8MP Color LCD Monitor CL-R813
- K222867 — AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
- K223050 — AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
- K223244 — Pristine Arthroscopic Visualization System
- K223482 — reVive Light Therapy® Wrinkle and Acne LED Device
- K213677 — Bonafix 2 Plus
- K220517 — IBS System
- K220991 — IntelliSep test
- K221004 — HOPKINS Telescopes
- K221011 — AI.ME System
- K221031 — Arthrex DualCompression Hindfoot Fusion Nail Implant System
- K221039 — Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y
- K221070 — DP4 Microneedling device
- K221603 — Kangaroo OMNI Enteral Feeding Pump (385400 ) +9 more
- K221735 — Mineral Collagen Composite Bioactive Moldable
- K221775 — LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
- K221904 — EK12 V2 Algorithm
- K221926 — Invictus® Bone Cement, Invictus Spinal Fixation System
- K222308 — Al Smile Aligner
- K222358 — Indigo Aspiration System - Lightning Flash
- K222405 — Smart SPACE Shoulder Planner and 3D Positioners
- K222808 — Penumbra System (Reperfusion Catheter RED 43)
- K222896 — AirRay
- K223140 — AEON-C Stand Alone System
- K223294 — SpineJack® Expansion Kit
- K213196 — MARVEL Growing Rods
- K213653 — 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
- K214076 — EsCem
- K221351 — Mechanical Guidewire
- K221896 — BreathID Hp System
- K222213 — Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)
- K222217 — ViewFlex Xtra Reprocessed ICE Catheter
- K222919 — GORE® ENFORM Biomaterial
- K220881 — INOUE BALLOON A
- DEN220012 — Tornier Pyrocarbon Humeral Head
- K212559 — CardioPhase® hsCRP
Data sourced from openFDA. This site is unofficial and independent of the FDA.