FDA 510(k) clearances — page 128
clearances on record, most recent first.
Clearances — page 128
12,701–12,800 of 175,699- K221636 — EMPHASYS Acetabular System
- K221929 — Smith+Nephew INTELLIO Tablet
- K222048 — Spectrum IQ Infusion System with Dose IQ Safety Software
- K222069 — Ez3D-i/E3
- K203503 — Camber Sacroiliac (SI) Fixation System
- K211178 — DURAMESH Mesh Suture
- K212189 — FibroLux
- K212222 — Soniquence Reusable 3 Button Fingerswitch Wand
- K213287 — StageOne Knee Cement Spacer Molds
- K213855 — Arrow Pressure Injectable Midline Catheter
- K213864 — Bonebridge Osteosynthesis Plating System
- K213983 — Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear
- K221085 — LiNA OperaScope Needle
- K221277 — Mygen M-3004 RF Generator M-3004
- K221414 — ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
- K221557 — Visera Hysterovideoscope Olympus HYF Type V
- K221644 — Synthetic Bone Putty
- K221932 — Omni Legend
- K221957 — Savewo ClassicMASK
- K222075 — CellFX System
- K222426 — Perfetta Moderate Medical Face Mask
- K201876 — Soteria Bed Barrier
- K220104 — Knee+
- K220177 — Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
- K220531 — FOX 810, FOX 980
- K220563 — Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System
- K220579 — Hybrid C70
- K220997 — Wireless TENS/EMS, Bruno, Aela
- K221038 — Disposable Medical Masks
- K221241 — DrAid for Radiology v1
- K221987 — Erchonia GVL
- K210935 — I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
- K213513 — Vented Vial Adapter 20mm
- K220933 — QT Scanner 2000 Model A
- K221040 — Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)
- K221255 — SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
- K221467 — INHANCETM Reverse Glenoid Peripheral Posts
- K221475 — MyClearALIGN Dental Aligner System
- K221507 — Disposable Blood Lancet
- K221541 — LimFlow ARC
- K221635 — IPL sapphire ice cooling hair remove device
- K221745 — Sterile Posterior Spinal Fixation System
- K221955 — Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
- K222325 — 8ch Wrist Coil
- K222387 — Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
- K211124 — Dose IQ Safety Software
- K211125 — Novum IQ Syringe Pump
- K212846 — Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
- K213718 — SOL-GUARD Safety Pull Button Collection Set
- K214118 — Riva Cem Automix
- K220067 — Medical Surgery Mask, Model:2626-7
- K220280 — Arrow Stiffening Stylet
- K220618 — SaliPen
- K221157 — JR Medic
- K221164 — Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl
- K221486 — INDEX BPM
- K221618 — Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System
- K221871 — Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
- K221970 — Lancing device
- K221999 — Ultrasound Transmission Gels
- K222558 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- K212248 — GlucoLeader Enhance 2 Blood Glucose Monitoring System
- K212370 — Leaderflex Mini and Leaderflex Nano
- K220676 — Blood Pressure Monitor
- K220799 — K-SHIELD Zen
- K221100 — Viz RV/LV
- K221111 — Non-Mydriatic Retinal Camera NW500
- K221189 — OLIZ LTB-1000A
- K221785 — TCL3 Motion Tracking System
- K222279 — Rusch Intermittent Urethral Catheters
- K222362 — Salvo® Spine System
- K222449 — Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
- DEN210052 — Vibrant System
- K213802 — StimOnTM Pain Relief System (GM2439)
- K214058 — Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer
- K220091 — Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
- K220159 — Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
- K220262 — Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
- K220357 — MedCAD AccuShape Titanium Patient-Specific Cranial Implant
- K220819 — BrainsWay Deep TMS System
- K220875 — HAcancellous PEEK-C Porous HA PEEK Cervical IBF System
- K221212 — Upper Arm Blood Pressure Monitor
- K221487 — NEOVEIL Staple Line Reinforcement
- K222256 — BonOs® Inject Bone Cement; NEO Pedicle Screw System
- K222263 — Arthrex Self Punching SwiveLock Suture Anchors
- K222277 — BriefCase
- K222278 — LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation
- K211298 — WiEMSpro
- K211841 — MRI Planner
- K212140 — GlucoSure Link Blood Glucose Monitoring System
- K212253 — Apollo Duet (Model : APD-4000)
- K213905 — ONX Large External Fixation System
- K220055 — Disposable, vinyl examination gloves, Yellow
- K221143 — Nitrile Exam Gloves (Blue, Black)
- K221206 — Compass Steerable Needle
- K221325 — CONDUIT Lateral Switch Plate
- K221365 — LapBox Tissue Containment Removal System
- K221648 — Iconic Latex Glove
- K221792 — Acute QC Strut and Components
- K221962 — LINQ II Insertable Cardiac Monitor
Data sourced from openFDA. This site is unofficial and independent of the FDA.