FDA 510(k) clearances — page 66
clearances on record, most recent first.
Clearances — page 66
6,501–6,600 of 176,479- K240269 — Nitrile Powder Free Examination Gloves Biodegradable (Green)
- K240918 — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia +1 more
- K241185 — CORGRIP* SR NG/NI Tube Retention System
- K242215 — Neurophet AQUA (V3.1)
- K242353 — QIAstat-Dx Respiratory Panel Mini
- K242397 — LYNX Photocoagulator
- K242625 — Freeze Point & Private Label Versions
- K242956 — LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle
- K242969 — Pantera Pro; Pantera LEO
- K242984 — BKS Revision System
- K243030 — Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
- K243031 — LCD Monitors C310S, G310S, C316S, G316S, C616W
- K243070 — Xpert® SA Nasal Complete
- K243173 — Salto Talaris Ankle PSI System
- K243174 — Cadence Ankle PSI System
- K243189 — TumorSight Viz
- K240391 — MUTARS® femoral stem cemented 160 mm and 200 mm
- K240543 — Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)
- K241007 — Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
- K241089 — KeyPrint KeyDenture Base
- K241554 — Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
- K242034 — Duet External Drainage and Monitoring System (EDMS)
- K242086 — MagDI System (MAG-01, DS-01)
- K242458 — ArgenZ MTZ
- K242462 — CEREC Cercon 4D CAD/CAM Blocks
- K242512 — ROCC Console
- K242560 — Manual Wheelchair (SYIV100-CA9221)
- K234060 — KIDNEYvault Portable Renal Perfusion System
- K240289 — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)
- K240865 — IDS-iSYS Free Testosterone
- K241324 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
- K241753 — Immediate Molar Implants
- K241876 — Vitesse (5.0)
- K241988 — ProSeal Closed System Bag Access
- K242073 — STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)
- K242183 — Fractional CO2 Laser Therapy System (EXFU CO2)
- K242513 — FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
- K242589 — Scarlet® AL-T
- K242829 — BluEX Lumbar Expandable Cage System
- K242847 — EXSYS DEXi (14 models)
- K242995 — OIC Small / Mini Fragment Plate System
- K243007 — CD Horizon Spinal System
- K243012 — MIM Symphony HDR Fusion
- K243057 — TrueFit Bolus; TrueFlex Bolus
- K240506 — KARL STORZ Holders
- K241398 — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
- K241478 — Tri-Wedge PTA Scoring Balloon Dilatation Catheter
- K241532 — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
- K241572 — ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
- K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000) +3 more
- K242099 — Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle
- K242193 — Arm Type Blood Pressure Monitor (BPM82)
- K242250 — PuraStat
- K243209 — nordicMEDiVA
- K222740 — Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch
- K240029 — Zio AT® device (A100A1001)
- K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
- K241170 — Dynamic TiBase; TRI Screws
- K242058 — Digital Prism Correction Feature (DPCF)
- K242157 — Anovo Surgical System (Model 6Ne)
- K242266 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
- K242554 — Arthrex VAL and VAL KreuLock Compression Screw System
- K222944 — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
- K232994 — Vittra APS Unique Flow
- K233054 — Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator +3 more
- K233378 — ABCcolla® Collagen ADM Scaffold
- K240226 — Pixie Skin Tag
- K240725 — PreXolid CAD/CAM abutments
- K240844 — Spectral CT 7500 RT
- K240916 — Surgical Face Mask (Tie on/ Ear loops)
- K241131 — edelweiss CAD/CAM T-BLOCK +5 more
- K241490 — Contour+ (MVision AI Segmentation)
- K241830 — Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask
- K241959 — 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD) +3 more
- K242132 — FREDDO
- K242372 — Mg OSTEOREVIVE, Mg OSTEOCRETE
- K242435 — Dental Barrier and Sleeves
- K242473 — Altis Single Incision Sling System (519650) +2 more
- K242813 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K242828 — Corplex P/ Theracor P/ Allacor P
- K242837 — BriefCase-Triage
- K242864 — ROSA® Knee System
- K242868 — Kinos Total Ankle System
- K242879 — dS Knee Coil 8ch 1.5T
- K243033 — dS Wrist coil 8ch 1.5T
- K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170) +2 more
- K211943 — Microlyte Ag/Lidocaine
- K240160 — EGPS Navigated Instruments
- K240218 — Electric Breast Pump (F5055)
- K240321 — MP Pin flat without thread (36BMP000020/MP20)
- K240408 — REMI-AI Rapid Detection Module (REMI-AI RDM)
- K240711 — Zipline Access Catheter
- K241242 — SIGNA MAGNUS
- K241267 — Hidroxa SE30
- K241337 — Electrically powered wheelchair (HP202)
- K242197 — IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)
- K242809 — Ascent Cardiorespiratory Diagnostic Software
- K242899 — NOVA Minimally Invasive System
- DEN230087 — AMStent® Tracheobronchial Covered Stent System
- K240114 — UltraEzAir® (UEA1A)
Data sourced from openFDA. This site is unofficial and independent of the FDA.