FDA 510(k) clearances — page 246
clearances on record, most recent first.
Clearances — page 246
24,501–24,600 of 175,699- K181066 — Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims
- K181563 — The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
- K181591 — Fixated Asfora BULLET CAGE® (FABC)
- K181707 — Everyway Wireless TENS & EMS Unit
- K181991 — NxStage Connected Health System
- K182315 — Magic Torque DLVR Guidewire
- K182325 — InMode RF System
- K182357 — HardyDisk AST Eravacycline 20µg (ERV20)
- K173127 — skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
- K181424 — PeDIA
- K181692 — 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack)
- K181773 — Synapse 3D Optional Tools
- K181795 — AST Model MA012 and MS019 Rehab Wheelchair
- K181904 — 5 FR Dual Lumen Piper PICC
- K181980 — OsseoScrew System
- K182290 — IBM iConnect Access
- K182335 — CPX 4 Breast Tissue Expander with Smooth Surface
- K180714 — Probe Covers for Thermometers
- K180916 — iNtuition-T1 Mapping and T2/T2* Mapping
- K181366 — REDAPT Porous Acetabular Shell
- K181611 — Comprehensive Reverse Shoulder System
- K182317 — AMADEO M-DR mini, AMADEO M-AX mini
- DEN070001 — NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
- K171947 — SOLOASSIST II
- K172418 — OpenSight
- K173960 — DePuy Corail AMT Hip Prosthesis
- K180029 — Malecot Nephrostomy Catheter/Stent Set
- K180144 — Agile Esophageal Stent System
- K180338 — Cellulize
- K180489 — TEVADAPTOR Closed Drug Reconstitution and Transfer System
- K181006 — BB-613 Watch Oximeter
- K181034 — Pocket Colposcope System
- K181200 — AEROmini Tracheobronchial Stent System
- K181616 — PSM 3-Way Silicone Foley Catheter
- K181665 — BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN
- K181702 — Tranquil-L Interbody System
- K181769 — Arthrex FiberTak Suture Anchor
- K181789 — VeriSuite
- K181926 — InVivo Web Viewer
- K182043 — Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)
- K182258 — AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm
- K182310 — Volpara Imaging Software
- K182345 — Spineology Navigation Instruments
- K173898 — MicroPort Orthopedics Total Hip Systems MR Labeling
- K180366 — EndoTool SubQ
- K181199 — Katalyst Mark 1 Muscle Stimulation System Model 2
- K181205 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- K181305 — OralTox Oral fluid Drug Test
- K181420 — Aequalis Flex Revive Shoulder System
- K181726 — Medline Patient Cables and Lead Wires
- K181783 — LOGIQ P9; LOGIQ P7
- K181995 — Chiral Surgical Pedicle Screw System
- K182340 — NICO Myriad
- K173141 — CSM Submerged3-L Implant System
- K173982 — FORTIFY Corpectomy Spacers
- K180781 — Bard Vertus Foley Catheter
- K180893 — IHM Technology Bandage
- K180894 — Magnetic Surgical System
- K180981 — Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
- K181229 — TirboLOX-C Cervical IBFD
- K181328 — T2 STRATOSPHERE Expandable Corpectomy System
- K181349 — Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens
- K181449 — Ortoma Treatment Solution - OTS
- K181734 — Beurer IPL 8500 device/ IPL VelvetSkin Pro
- K182080 — Scope Antifogging System
- K182286 — Oh'Care Lite Smart Blood Glucose Monitoring System
- K171904 — Tandry Locking Plate System
- K173830 — MAC VU360 Resting ECG Analysis System
- K181233 — Elecsys FT4 III
- K181320 — Caprolon
- K181337 — Sypher Spacer System
- K181390 — Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
- K181620 — Endoscopic Linear Cutting Staplers and Loading Units for Single Use
- K181653 — Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
- K182157 — BioSign Flu A+B
- K182243 — The CVC WAND Safety Introducer with Valved Peelable Sheath
- K173871 — CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
- K180933 — DenTek Ultimate Dental Guard
- K181632 — Venacure 1470 Pro
- K181721 — Ceracell Ortho Foam
- K182260 — PALACOS MV
- K181102 — ThermaCare Quick Therapy TENS
- K173676 — A-FIT
- K173827 — LightScalpel
- K173910 — Impress SFS System
- K173926 — DORADOnova MR3T
- K180182 — Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
- K180369 — Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
- K180871 — Portable Nebulizer
- K180875 — POLY REJUV
- K181598 — Prime E-CLASS XLPE Liner
- K181874 — MX40 Mobile Digital X-ray System
- K182213 — QT Ultrasound Breast Scanner - 1
- K182214 — DizzyDoctor System 1.0.0
- K182223 — Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
- K172450 — TENS device-HeadaTerm, eEspress
- K173933 — Sorrento Bioglass Bone Graft Substitute
- K180053 — Sof-Flex Ureteral Stent Set
- K180215 — DYNA-LINK ELITE Stand-Alone Anterior Lumbar System
- K181000 — SelectFlex 072 Neurovascular Access System
Data sourced from openFDA. This site is unofficial and independent of the FDA.