FDA 510(k) clearances — page 28
clearances on record, most recent first.
Clearances — page 28
2,701–2,800 of 175,620- K252045 — Ion Endoluminal System (IF1000)
- K252644 — PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture
- K253053 — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
- K243645 — IC-Flow Imaging System 2.0
- K250205 — Babio® Virus Transport Kit (Non-inactivating)
- K250388 — ENDOFLATOR +
- K251743 — SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System
- K252315 — Santreva-ATK Endovascular Revasculariztion Catheter
- DEN240067 — KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
- K241868 — xR IVD
- K242859 — VEGA
- K243920 — Purema H Hemoconcentrator - Pediatric
- K243990 — BondEase 2 Topical Skin Adhesive
- K244035 — Portable mesh nebulizer (JM821)
- K250128 — Single Use Suction-Evacuation Ureteral Access Sheath
- K250408 — Alegria Flash ENA Screen
- K250450 — Coated hip implants
- K250649 — Bunkerhill ECG-EF
- K250777 — Sonicaid Team3
- K250953 — EQUIA LC ONE
- K251002 — Videa Dental AI
- K251100 — IPGTFL-02
- K251167 — uDR Aurora CX
- K251689 — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)
- K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
- K252285 — Well-Root PT
- K252613 — Unscented menstrual three-piece applicator tampon
- K252647 — Tapestry Biointegrative Implant
- K252657 — Impact PEEK Union Nail System
- K252662 — UniBur
- K250369 — Axial3D Insight
- K250883 — ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
- K251377 — Magic InBra
- K251479 — Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))
- K251597 — InnerView System
- K251649 — Sunny Plus (Sunny)
- K251905 — Normatec Elite Hip
- K252428 — Electric Wheelchair (Model P2)
- K243752 — Double Tube Herbst Appliance
- K244006 — FG Bone Graft M
- K251095 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
- 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); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)
- K252615 — Ruthless Spine RJB
- K242287 — SFIT Abutment
- K251650 — Insight Enhanced DRF (EN-1002-01)
- K251676 — Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)
- 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 (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.