FDA 510(k) clearances — page 198
clearances on record, most recent first.
Clearances — page 198
19,701–19,800 of 176,479- K190600 — ORION Spinal System
- K191591 — BB Base 3D printing resin for denture base
- K192723 — Coloring Liquid
- K201334 — Keystone Dental XL Dental Implant System
- K202012 — Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
- K192597 — Cytrans Granules
- K192845 — Sperm Freeze, Sperm Fridge
- K193240 — Universal Cylinder Applicator Family
- K193492 — 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
- K200648 — EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
- K201159 — WallFlex Colonic Stent System with Anchor Lock Delivery System
- K201177 — RadGil2
- K201352 — 3D Auto LAA
- K201399 — HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head
- K193408 — Sirona Dental CAD/CAM System with CEREC Chairside Software
- K191708 — Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head
- K192682 — Orthocem, Ortho Bite
- K200064 — OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft
- K200775 — LOOP LED Curing Light System
- K200848 — Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit
- K201010 — Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite
- K201518 — Route 92 Medical 088 Access System
- K201632 — TOMTEC-ARENA
- K202068 — The AIO Solution 3.0
- K202276 — BracePaste Band and Build LC
- K181645 — StimaWELL 120MTRS
- K192611 — Cuffix
- K192944 — AncestryDNA Factor V Leiden Genetic Health Risk Test
- K192947 — AncestryDNA Saliva Collection Kit
- K193046 — Straumann® Retentive System Novaloc TiN Abutments
- K193429 — Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
- K200133 — hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
- K200822 — Braid
- K200895 — Univers Revers Modular Glenoid System, Half Augment Baseplate
- K201232 — Limbus Contour
- K201444 — Syngo.via RT Image Suite
- K201916 — Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator
- K201960 — SpaceFlex Knee - 80mm Size
- K201961 — IlluminOss Photodynamic Bone Stabilization System
- K192620 — SNA-001 Silver Photoparticle Topical Gel
- K193312 — UNIKO PointCloud Knee Instruments
- K200529 — Orion
- K200534 — VisualEyes
- K200763 — Osteo-site Vertebral Balloon
- K200838 — Tyece OTC TENS Model
- K201054 — SOMNOscreen plus
- K201099 — BD PhaSeal Optima Closed System Drug Transfer Device
- K201174 — TruDi Curette
- K201248 — Syringe Holder accessory
- K201637 — Aurora Evacuator +Coag
- K201871 — Surgical Mask
- K191296 — Pointe Scientific Creatinine Kinase (CK) Reagent Set
- K193175 — Lateralized Glenosphere
- K193264 — Disposable High Speed Air Turbine Handpiece
- K200359 — NuEra Tight, NuEra Tight EMS
- K200740 — HD Video Rhino Laryngoscope
- K200981 — Mega Plus MIS Spine System
- K201286 — 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch
- K201588 — CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice
- K201623 — LION Photocoagulator
- K201722 — Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
- K201933 — ImagenSPECT 3.0
- K201953 — OMNI PLUS Surgical System
- K192551 — 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle
- K193626 — Masimo Rad-97 Pulse CO-Oximeter and Accessories
- K200592 — GS Medical AnyPlus PEEK Cage System
- K201567 — Precice® Bone Transport System
- K201585 — Monterey AL Interbody System
- K193006 — MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system
- DEN200001 — Cell-Free DNA BCT
- K192075 — ProSeal Closed System drug Transfer Device (CSTD)
- K192657 — Sterile High-pressure Angiographic Syringes for Single-use
- K193082 — Fountain ValveTip Infusion Catheter
- K193130 — MVP Aligner System
- K193207 — TaiChiA
- K193278 — MedSource CathMED IV Catheter
- K200809 — D-LUX+
- K200990 — VIDAvision
- K201006 — K2M Navigation Instruments
- K201067 — CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed))
- K201244 — Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
- K201310 — Accipiolx
- K201619 — EndoTool IV System
- K201883 — 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor
- K201926 — CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System
- K201932 — X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
- K201938 — LZI Fentanyl II Enzyme Immunoassay
- K191644 — TK Safety Needle
- K193066 — Steripack cases and Tray Systems
- K200324 — NHancer Rx
- K200353 — ManaFlow
- K200858 — Mini Sterilizable Tray
- K200890 — Invacare Perfecto2V Oxygen Concentrator
- K201076 — Anchor Dual Lumen Guidewire Catheter
- K201143 — VICRYL Mesh
- K201502 — Vitra 810
- K201521 — Medina Anterior Cervical Plate System
- K201641 — Disposable Laparoscope Trocar
- K201667 — Midmark Extraoral Imaging System (EOIS)
- K201750 — Pentaray Nav eco High-Density Mapping Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.