FDA 510(k) clearances — page 270
clearances on record, most recent first.
Clearances — page 270
26,901–27,000 of 175,699- K173524 — ANAX 5.5 Spinal System
- K173621 — Advocate PTA Catheter
- K170279 — Disposable High Pressure Syringe
- K170898 — Wittich Nitinol Stone Basket
- K170988 — DropSafe Safety Pen Needle
- K171956 — Sterile Endoscope Biopsy Sampling Needle
- K172276 — Xario 200 Diagnostic Ultrasound System V6.0
- K172432 — SporView Rapid Read Biological Indicator
- K172737 — MESIRE - Balloon Sinus Dilatation System
- K173137 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
- K173392 — Pure-Vu System
- K173467 — Advanced Diffusion Analysis (ADA) application
- K173536 — T2Candida 1.1 Panel
- K170276 — Safety Blood Collection Device for Single Use
- K172405 — SNIPER STAPLE SYSTEM, NON-STERILE
- K173480 — Crystalsert Lens Delivery System
- K173484 — CorticaLINK Spinal Fusion Platform
- K173612 — Optima XR646 HD
- K172713 — Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set
- K172722 — Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
- K171186 — Cerebrotech CMS-5000
- K171553 — W&H Assistina Twin
- K171677 — Clear Guide SCENERGY
- K171928 — Med-Hot Thermal Imaging Systems
- K172222 — 8ch Flex Suite
- K172302 — InMode PLUS System
- K172445 — RoyalGuard Surgical Gown, i600, Breathable
- K172714 — LipiVage
- K172731 — VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
- K172756 — Varian cage
- K172786 — MDS Plating System
- K172966 — CMS-2000 Central Monitoring System
- K173131 — Rexious Spinal Fixation System
- K173462 — Wireless Pain Relieve Device Model: LT5018C
- K173475 — Merge PACS
- K170046 — Lilium a-200E
- K170720 — Portex Blue Line Ultra Paediatric Tracheosomy Tube
- K170818 — Craniomaxillofacial Distraction System (CMFD)
- K171198 — NeuViz 16 Essence Multi-slice CT Scanner System
- K171336 — Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath
- K171513 — Lunderquist Extra Stiff Wire Guide
- K172010 — gel-e Bandage
- K172270 — gammaCore-2
- K172578 — Equipment Pouch
- K172734 — Single Use Electrosurgical Snare SD-400
- K172908 — Q-Switched Nd:YAG Laser System
- K172912 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL)
- K173000 — Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System
- K173117 — NuVasive® VersaTie System
- K173267 — MasterLoc Stem: Lateralized Plus
- K173458 — ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
- K170797 — wettrust D2care
- K170934 — C3 Wave System
- K172425 — OrthoPediatrics Wrist Fusion Plate
- K172468 — 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
- K172530 — BEAUTIFIL Flow Plus X
- K173091 — Boundary Anterior Lumbar Buttress Plate
- K173153 — Vertera Spine Coalesce Thoracolumbar Interbody Fusion System
- K171447 — OxyPure Color Silicone Hydrogel Soft Contact Lenses
- K172529 — Vivaer ARC Stylus
- K172561 — Disposable Circular Stapler
- K172618 — SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
- K172707 — Renamel Microfill
- K172993 — P20 Series Digital Color Doppler Ultrasound System
- K173126 — Arisstos Spinal System
- K171771 — ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
- K172085 — PhotoFix Decellularized Bovine Pericardium
- K172419 — Velofix TLIF Cage
- K172629 — Panther Fusion AdV/hMPV/RV Assay
- K172876 — PowerDot PD-01M
- K173260 — SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System
- K173470 — ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath
- K173538 — Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
- K170392 — S.I.N. Implant System
- K170553 — Altus Spine Interbody Fusion System
- K171185 — IR Type Implant System
- K171352 — EZFluence
- K171773 — Straumann n!ce Glass Ceramic A14 Blocks
- K171935 — Alevicyn SG Antimicrobial Gel
- K172008 — ARIX Humerus System
- K172255 — MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
- K172503 — MR Conditional Cup Electrode, MR Conditional Webb Electrode
- K172666 — CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor
- K172819 — LightWalker Laser System Family
- K172931 — DUS-6000 Digital Ultrasonic Diagnostic Imaging System
- K173038 — CuRAS Nd:YAG Laser
- K173058 — P10 Series Digital Color Doppler Ultrasound System
- K173129 — PRECICE System
- K173148 — ACIF
- K173209 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL
- K173266 — Octane aspiration system
- K162718 — Foot Drop System (Model XFT-2001D)
- K170868 — FIXIT Threaded Anchor System
- K171571 — NexSite HD, Hemodialysis Step Tip Catheter (60cm)
- K171578 — Infrared thermometer
- K171934 — Birmingham Hip (BH) Dual Mobility Insert
- K172225 — Atlantis Abutment for MIS Implant
- K172469 — TiLock Modular Spinal System
- K172538 — Disposable Linear Stapler, Disposable Linear Cutter
- K172637 — HeRO Graft
Data sourced from openFDA. This site is unofficial and independent of the FDA.