FDA 510(k) clearances — page 274
clearances on record, most recent first.
Clearances — page 274
27,301–27,400 of 175,699- K172333 — Sysmex CS-5100
- K172447 — JO Gelato Flavored Personal Lubricants
- K172572 — Stryker Upper-Face AXS screws and Mid-Face AXS screws
- K173080 — IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
- K173318 — Rapid HB, Rapid LB, Rapid MB
- K163659 — Crystal Vision
- K170426 — AN85/AN86 EO Indicators
- K170917 — Bi-Ostetic Bioactive Glass Foam
- K171008 — Anorganic Bone Mineral with Collagen in Delivery Applicator
- K171525 — Intellijoint HIP Generation 2B System
- K171643 — Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed
- K172236 — Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled
- K172296 — Stethee Pro
- K172326 — Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
- K172351 — AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert
- K172402 — ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
- K172404 — SenoBright HD
- K172646 — XIDF-AWS801, Angio Workstation, V7.0
- K172943 — Flex-Thread Fibula Pin System
- DEN170030 — VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody
- K162738 — Puritan Bennett 980 Ventilator System
- K170345 — SOFTDISO
- K170429 — Tyvek Sterilization Pouches with Chevron Seal
- K170466 — Automatic Blood Pressure Monitor Model LD-518 & LD-537
- K170585 — Skylife
- K171926 — C5 Diagnostic Ultrasound System
- K171979 — Tubing Pack
- K172028 — Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
- K172038 — Trocar
- K172077 — Cutera enlighten III Laser System
- K172087 — SANGRAY
- K172133 — ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
- K172534 — LINACwatch, LinacView
- K172803 — Infinitt PACS 7.0
- K172815 — 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
- K173104 — Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly
- K173122 — Abbott Architect Free T4
- K173132 — ASPIRE Cristalle
- K173138 — Biim Diagnostic Ultrasound System
- K173184 — Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
- K171142 — Healing Cap Multi-Unit Titanium
- K171831 — Intra-Lock Bone Fixation System
- K171931 — Celerity ECG Cable Accessory Pack
- K172323 — Omnia Medical VBR
- K172325 — Rhapsody H-30 Holmium Laser System
- K172341 — NuVasive® Modulus TLIF Interbody System
- K172417 — SILC® Fixation System
- K172994 — EPI K Console
- K173022 — SeaSpine Ventura NanoMetalene System
- K173046 — Cocoon Portable Handheld X-Ray System
- K173094 — OrthoVision
- K162652 — Smart Photon Micro-current Device, Model: EP-300
- K163050 — Advance Medical Designs, Inc. Sterile Ultrasound Gel
- K170226 — iTotal Family Reusable Instrument Tray
- K170293 — Emit II Plus Cocaine Metabolite Assay
- K170307 — SunCHECK
- K170423 — DentureID Microchip
- K170454 — Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U
- K171914 — Cortina Lumbar Cage System
- K171946 — Gel-Bead
- K172132 — CleanCision Wound Retraction and Protection System
- K172200 — 3880 MRI Patient Monitoring System
- K172334 — Ortus Expandable Lumbar Interbody Fusion System
- K172455 — CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit
- K172600 — AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal
- K172617 — Treace Medical Concepts (TMC) Compression Screw System
- K172626 — Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir
- K172808 — CosmoLock Pedicle Screw System
- K172937 — Colorado Therapeutics Xenograft Implant
- K172970 — M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound
- K173031 — AtriClip LAA Exclusion System with Preloaded PRO·V Clip
- K173095 — VIPER PRIME Screws, VIPER PRIME Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations
- K173242 — CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)
- K170320 — Alinity c ICT Sample Diluent
- K171575 — ENFLU 18 (enflufocon A) Daily Wear Contact Lens
- K171751 — SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module
- K172000 — ClearLumen II Peripheral Thrombectomy System
- K172251 — UTS Stem
- K172307 — Dynamic Coronary Roadmap 2.0
- K172951 — Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)
- K170056 — IRENE Cannulated Screw System
- K170317 — Alinity i Total ß-hCG Reagent Kit, Alinity i System
- K170612 — STERILE VINYL EXAMINATION GLOVES, Powder Free
- K171001 — Monosyn Quick Synthetic Absorbable Surgical Suture
- K171277 — Reprocessed Inquiry Steerable Diagnostic EP Catheter
- K171293 — G3 Active Plate® Miniature System
- K171489 — Acapella Cervical Spacer System
- K171640 — M-ARS ACL: Anatomic Ribbon Surgery System
- K171647 — BeneLife Premium Facial Treatment Pack, Model: QZ0701A
- K171938 — KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set
- K171996 — TruWave Disposable Pressure Transducer
- K172213 — MECRON Cannulated Screw System
- K172254 — Lyme B. burgdorferi (IgM) MarStripe Test
- K172282 — Panther Fusion Paraflu Assay
- K172343 — Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
- K172542 — Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.
- K172546 — AnyPlus® Spinal Fixation System
- K172585 — Liberty Anterior Cervical Plate
- K172805 — gi-4000 Electrosurgical Generator
- K173063 — ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
Data sourced from openFDA. This site is unofficial and independent of the FDA.