FDA 510(k) clearances — page 37
clearances on record, most recent first.
Clearances — page 37
3,601–3,700 of 176,479- K251221 — Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)
- K251386 — ECHELON Synergy
- K251446 — PlasmaFlow X Compression Sleeve Device (XPF0001)
- K251623 — Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)
- K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450)
- K251902 — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)
- K252035 — DENTURE SOFT EX (Pink set) +6 more
- K252615 — Ruthless Spine RJB
- K242287 — SFIT Abutment
- K251650 — Insight Enhanced DRF (EN-1002-01)
- K251676 — Medline Microtek C-Flo Bag Decanter, Sterile (2000S) +3 more
- K252540 — ACCUJECT Injector Set 2.1-1P (LP604590)
- K250237 — InferOperate Suite
- K250609 — Sober Self-Test
- K251780 — iGPS Navigation Instruments
- K251869 — Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
- K251914 — IPL Hair Removal Device (6 models)
- K252128 — Zener® (model ZEN-001-B1)
- K252443 — SpaceFix Shoulder Spacer
- K252598 — Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
- K250689 — CloudTMS Edge
- K251449 — BrainsWay Deep TMS System
- K243864 — BONX805
- K250040 — uWS-Angio
- K250047 — bite away two
- K250059 — BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)
- K250445 — Fast Warm - NX
- K250628 — DynaNail TTC Fusion System
- K250986 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
- K251083 — Compact II
- K251170 — Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
- K251368 — FETOLY
- K251518 — Volta AF-Xplorer II
- K251820 — ViewMateTM Ultrasound System
- K251843 — Erchonia EVRL
- K252027 — Vertex(TM) Catheter
- K252189 — LED Light Therapy Mask (2311, 2344, 2457, 2458)
- K252225 — PowerKnot High Strength Sutures
- K252554 — Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
- K252562 — Spine & Trauma Navigation Instruments
- K252576 — Legend X Platform
- K252586 — CADDIE
- K252593 — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
- K252595 — Stethophone Pro
- K242314 — Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)
- K243926 — Vivatmo pro-S
- K250216 — OsteoProbe (OP-100)
- K250507 — Hypertension Notification Feature (HTNF)
- K250797 — UV5000 Handle
- K251158 — PowerWire® 14 Radiofrequency Guidewire Kit
- K251316 — Mazor X System / Mazor X Stealth Edition
- K251320 — XTRA4
- K251399 — SIGNA Sprint
- K251758 — Serafin®
- K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
- K252374 — Nylon flexTAP(R)
- K252520 — SEFRIA Hydrocodone Oral Fluid
- K244002 — AngioWaveNet
- K250464 — Enlight 2100 (TPL-E2103-0)
- K250734 — OptiLUV Device
- K251573 — VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens
- K251817 — da Vinci SP Surgical System (SP1098)
- K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A) +3 more
- K252527 — Surfacer Inside-Out Access Catheter System
- K252530 — OptiVu Shoulder
- K252580 — iQ200 Series
- K243846 — Access anti-HAV
- K250483 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
- K250922 — Edema Guard Monitor (EGM) CardioSet-001
- K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
- K251072 — Segmentron Viewer
- K251682 — MuscleView 2.0
- K251773 — Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant +3 more
- K251891 — Electric Wheelchair (GY-E001)
- K252180 — Bicarby Dialysate RFP-404 (RFP-404-W) +7 more
- K252181 — AquaA
- K252477 — Hybrid Viewer (00859873006240)
- K252524 — Quadsense (Quadsense and Quadsense Pro)
- K252608 — AI-Rad Companion Prostate MR
- K250229 — Dual Action Tissue Closure Device
- K250928 — OmniTom Elite with PCD
- K250960 — DUO Microcatheter
- K251227 — da Vinci Surgical System (IS5000)
- K251394 — Momcozy Wearable Breast Pump (BP223)
- K251610 — qER-CTA (v1.0)
- K251754 — Wearable Breast Pump (Model S33)
- K251892 — MAXXOS P.A.C.E. Foot & Ankle Plating System
- K251931 — BioTraceIO Vision (V1.7)
- K251957 — Coaptium Connect with Tissium Light
- K243795 — pREBOA-PRO Catheter
- K244038 — High Pressure Tubing
- K250095 — All-Suture Dual Anchor System
- K250132 — Ureteral Access Sheath
- K250460 — WatchPAT400 (WP400)
- K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
- K251022 — 3D-SHAPER
- K251250 — ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System (VMM-ICE-02)
- K251317 — SOLOPASS 2.0 System
- K251753 — GenaCheck COVID-19 Rapid Self-Test
- K252478 — Vaccess CT Low-Profile Power-Injectable Implantable Port +2 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.