FDA 510(k) clearances — page 118
clearances on record, most recent first.
Clearances — page 118
11,701–11,800 of 175,620- K222733 — Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)
- K213054 — Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
- K220774 — RobPath® Total Hip Application
- K220822 — 3D-SHAPER
- K220951 — PMT Facet Fixation System (PMT FFS)
- K221280 — Vesseal
- K221598 — Wearable breast pump
- K222086 — Inogen Rove 4 Portable Oxygen Concentrator
- K222117 — Swang-Ganz IQ pulmonary artery catheter
- K222242 — FloPatch FP120
- K222552 — 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)
- K222650 — Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate
- K222753 — SeaSpine 7D Navigation Instruments
- K222916 — US 450 Diode Laser Equipment
- K223193 — AIROS 8P Sequential Compression Device
- K223195 — AIROS 6P Sequential Compression Device
- K223275 — CELLO II Balloon Guide Catheter
- K223402 — HemosIL von Willebrand Factor Antigen
- K223403 — LIAISON Anti-HAV; LIAISON XS
- K211800 — Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
- K213210 — Oxygen Concentrator, Model JAY-5AW
- K220667 — Sleeved IC
- K220826 — LED Curing Light
- K221182 — Southern Transforaminal Lumbar Interbody Fusion (TLIF)
- K221444 — LED Eye Perfector, model: EY-36A, EY-36B
- K221862 — YY-A02-B Overlapped Compression Therapy
- K222038 — CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System
- K222471 — IRRAflow Active Fluid Exchange System (AFES)
- K222750 — Yomi Robotic System
- K222837 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
- K223112 — MAVERICK Mini External Fixation System
- K223239 — 8ch Wrist Coil
- K223487 — InkSpace Imaging Body Array
- K212567 — PVC Hydrophilic Urethral Catheter
- K213919 — Dexcom G7 Continuous Glucose Monitoring System
- K220772 — HydroMID 4F Single Lumen Midline Catheter
- K220843 — OAKTREE Anterior Lumbar Plate and Screw System
- K221626 — Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
- K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
- K221842 — Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
- K222441 — Ultrasound System 2300
- K223045 — 3-Ply Disposable Medical Mask
- K223077 — ViewFlex Xtra ICE Catheter
- K223281 — Disposable Nitrile Examination Glove
- K223394 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)
- K223410 — Cios Select (VA21) Flat Panel
- K221021 — Femoral Trochanteric Nail System Neonail
- K222219 — R2 Studio Q/RCT820
- K222320 — MedDream
- K222385 — Bifurcated Needle
- K222541 — Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
- K222575 — HurriChem Device Kit
- K222626 — Dental Zirconia Ceramic
- K222706 — iCE-SG2 Subcutaneous Electrode Kit
- K223247 — Swoop Portable MR Imaging System
- K223386 — Optima Coil System
- K223409 — Cios Select (VA21) Image Intensifier
- K223632 — Premier's MultiMatch Universal Chameleon Restorative Composite
- K213169 — BPAP System
- K221612 — ClearRead CT
- K221806 — TruLift Lateral Expandable Spacer System & Lateral Plate System
- K222137 — OK Plus Indicator
- K222614 — Zavation Spinal System
- K222669 — Cryopush Cold Compression Device
- K222681 — Altaviz Needle Kit
- K222689 — Mallya Injection Pen Adapter (Mallya® for Solostar®)
- K222692 — BriefCase
- K223055 — Disposable Medical Face Mask
- K222019 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
- K222815 — Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl
- K223004 — Disposable Nitrile Examination Gloves
- K212866 — truSculpt flex
- K222713 — White Nitrile Powder Free Patient Examination Glove, Non Sterile
- K222715 — Black Nitrile Powder Free Patient Examination Glove, Non Sterile
- K222720 — Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
- K213465 — CardioGraphe
- K220390 — CreoDent Solidex Customized Abutment and Screw
- K220611 — SUREcore Plus Biopsy Instrument
- K220688 — SilentZPro 2.0
- K220778 — Chemical Indicator for Steam
- K221113 — Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
- K221141 — PageWriter TC35 Cardiograph
- K221401 — Self-Cath and Self-Cath Plus
- K221410 — Maestro Platform
- K221590 — NaviCam Small Bowel Capsule Endoscopy System
- K223072 — PENTAX Medical Video Esophagoscope EE17-J10
- K223211 — INHANCETM Shoulder System Humeral Stems and Stemless
- K223218 — Parietene Macroporous Mesh
- K223353 — DropSafeTM SicuraTM
- K223369 — truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184
- K213768 — Bolt Navigation System
- K220786 — STAR Apollo Mapping System
- K221747 — Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
- K221791 — ProBeam 360° Proton Therapy System
- K222118 — 2-Way 100% Silicone Cleartract Catheter
- K222125 — Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G
- K222297 — CentriMag Pre-connected Pack
- K222340 — Chartis Precision Catheter
- K222368 — MIST IC
- K222516 — Mercury® II Spinal System
Data sourced from openFDA. This site is unofficial and independent of the FDA.