FDA 510(k) clearances — page 336
clearances on record, most recent first.
Clearances — page 336
33,501–33,600 of 175,770- K152315 — JOURNEY II Uni Tibial Base and Insert
- K152338 — VERTEX(r) Reconstruction System
- K152795 — RiverLon (Nylon) Suture
- K143306 — ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe
- K150241 — Genesis II XLPE Resurfacing Patellar Components
- K150780 — Acetabular Cup Orientation System
- K151629 — Guardian 1000
- K151769 — Anchorage 2 CP System
- K151865 — PremiPatch PTFE Pledget
- K151954 — A7 Anesthesia System
- K152152 — Codman Certas Plus Programmable Valve
- K152169 — Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts
- K152363 — Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
- K152457 — CD HORIZON Spinal System
- K152607 — Express SD Biliary Monorail Premounted Stent System
- K152801 — ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT
- K152870 — BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit
- K152874 — BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit
- K153003 — SIGNA Pioneer
- K150270 — ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set
- K151182 — LiquiBand Exceed
- K151489 — Retrieval bag system
- K151882 — Varian Treatment (VTx)
- K152028 — Volpara Imaging Software
- K152092 — Resection Electrodes
- K152665 — PolarCath Peripheral Dilatation System
- K143235 — RF20000a Controller, FLOW 50 Wand
- K143670 — ICS CHARTR EP 200 WITH VEMP
- K150141 — Orthodontics Bracket
- K150203 — Medentika CAD/CAM Abutments
- K150323 — FEMTO LDV Z8 Surgical Laser
- K150606 — Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive
- K150936 — SureClip
- K151336 — LightStim Professional 2-Panel Light
- K151593 — Cellvizio 100 Series System with Confocal Miniprobes
- K151600 — R-40 EEG Amplifier
- K151821 — ER-REBOA Catheter
- K152106 — Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart
- K152371 — Vantage Titan 3T
- K152474 — Avitus Bone Harvester
- K152560 — Bard Snare Retrieval Kit
- K152677 — geko T-2 Neuromuscular Stimulator
- K152800 — illumigene Mycoplasma DNA Amplification Assay
- K150314 — Masimo MightySat Rx Fingertip Pulse Oximeter
- K150741 — TSolution One w/ACG surgical System
- K150902 — 330psi Extension Y-Line with Dual Check Valve
- K151386 — C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
- K151578 — Carbamazepine Gen 4
- K151893 — P.R.O. CG Manual Wheelchair
- K151895 — Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
- K151911 — WorkMate Claris System, WorkMate Claris System Display Plus
- K152096 — DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive
- K152180 — PEAK
- K152784 — Pacel Bipolar Pacing Catheters
- K142505 — ClearPoint System
- K150474 — NuVasive VuePoint II OCT System
- K150855 — H-MAX S Femoral Hip System
- K151415 — Oregon Scientific
- K151646 — ProTech Plus
- K151736 — Philips IntelliVue GuardianSoftware
- K151836 — NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK
- K151938 — S4 Cervical Spinal and Occiput Systems
- K151942 — EVS 3643
- K152066 — Luminesse Anterior Zirconia AT
- K152261 — PICC Tip Positioning Aid
- K152693 — CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels
- K152694 — Diamondback 360 Peripheral Orbital Atherectomy System
- K152704 — iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System
- K152709 — HI-TORQUE BALANCE
- K152726 — JOURNEY II XR Knee System
- K152763 — Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
- K152770 — ProBP 2400 Digital Blood Pressure Device
- K152788 — EOS System
- K152867 — MHI-TM2000 Linear Accelerator System, VERO, Imavis
- K150153 — Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant
- K150160 — Temple Touch Pro (TTP) Non-invasive temperature monitoring system
- K150308 — Palm TENS
- K151389 — Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
- K151674 — Ultraviolet Sun Tanning Lamp
- K151956 — Admira Fusion x-tra
- K152014 — MTS300 Multiple Tray Sterilization System
- K152574 — Navio
- K143617 — AquaC UNO H
- K150156 — Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel
- K150232 — Radifocus Optitorque Angiographic Catheter
- K150804 — QBioScan
- K151636 — AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
- K152156 — Opticage Expandable Interbody Fusion Device
- K150037 — Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
- K150918 — PASS OCT Spinal System
- K151347 — MIS Spine Frame Instrument Case
- K151479 — EV-820 OTC Pain Relief TENS
- K151565 — Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit
- K151640 — ELTRAC 471
- K151648 — Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System
- K151671 — Disposable Multistage Dilation Balloon Catheter
- K151844 — Rainbow Shade
- K152094 — GR40CW
- K152362 — Terumo SurGuard 3 Safety Hypodermic Needle
- K152663 — Bladeless Optical Obturators
Data sourced from openFDA. This site is unofficial and independent of the FDA.